Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines

The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3, 4 and 5 months of age.

In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen; Drug: Paracetamol

• Study Type: Interventional
• Enrollment (Actual): 850
• Phase: Phase 4

Contacts and Locations

Study Locations

• Romania
  • Bacau, Romania, 600316
    • GSK Investigational Site
  • Braila, Romania, 810289
    • GSK Investigational Site
  • Braila, Romania, 810346
    • GSK Investigational Site
  • Brasov, Romania, 500260
    • GSK Investigational Site
  • Brasov, Romania, 500366
    • GSK Investigational Site
  • Brasov, Romania, 500063
    • GSK Investigational Site
  • Bucharest, Romania, 077190
    • GSK Investigational Site
  • Bucharest, Romania, 051821
    • GSK Investigational Site
  • Bucuresti, Romania, 030442
    • GSK Investigational Site
  • Bucuresti, Romania, 050734
    • GSK Investigational Site
  • Calarasi, Romania, 910160
    • GSK Investigational Site
  • Cluj-Napoca, Romania, 400217
    • GSK Investigational Site
  • Constanta, Romania, 900709
    • GSK Investigational Site
  • Constanta, Romania, 900721
    • GSK Investigational Site
  • Galati, Romania, 800099
    • GSK Investigational Site
  • Galati, Romania, 800179
    • GSK Investigational Site
  • Galati, Romania, 800235
    • GSK Investigational Site
  • Galati, Romania, 800322
    • GSK Investigational Site
  • Galati, Romania, 800394
    • GSK Investigational Site
  • Iasi, Romania, 700115
    • GSK Investigational Site
  • Pantelimon, Romania, 77145
    • GSK Investigational Site
  • Sibiu, Romania, 550166
    • GSK Investigational Site
  • Timisoara, Romania, 300593
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (.
• Indication, other than specified in the protocol, for prophylactic or therapeutic antipyretic treatment during the study period.
• Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF.
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations.
• History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
• History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol.
• History of any seizures or progressive neurological disease.
• Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination .
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during entire study period.
• Any contraindication to treatment with ibuprofen as described in the ibuprofen summary of product characteristics (SPC).
• Any contraindication to treatment with paracetamol as described in the paracetamol SPC.
• Body weight < 5 kg at the time of enrolment.
• Child in care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group IIBU; Immediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Ibuprofen; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Nurofen for Children
Active Comparator: Group DIBU; Delayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Ibuprofen; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Nurofen for Children
Active Comparator: Group NIBU; No ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose
Experimental: Group IPARA; Immediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Paracetamol; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Panadol Baby
Experimental: Group DPARA; Delayed paracetamol group: subjects receiving delayed paracetamol treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Paracetamol; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Panadol Baby
Active Comparator: Group NPARA; No paracetamol group: subjects receiving no prophylactic paracetamol treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose
Experimental: Group IIBU-IIBU; 1/3 of the subjects from the primary IIBU group receiving immediate ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Ibuprofen; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Nurofen for Children
Experimental: Group IIBU-DIBU; 1/3 of the subjects from the primary IIBU group receiving delayed ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose
Experimental: Group IIBU-NIBU; 1/3 of the subjects from the primary IIBU group receiving no prophylactic ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Ibuprofen; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Nurofen for Children
Experimental: Group DIBU-IIBU; 1/3 of the subjects from the primary DIBU group receiving immediate ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Ibuprofen; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Nurofen for Children
Experimental: Group DIBU-DIBU; 1/3 of the subjects from the primary DIBU group receiving delayed ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Ibuprofen; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Nurofen for Children
Experimental: Group DIBU-NIBU; 1/3 of the subjects from the primary DIBU group receiving no prophylactic ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose
Experimental: Group NIBU-IIBU; 1/3 of the subjects from the primary NIBU group receiving immediate ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Ibuprofen; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Nurofen for Children
Experimental: Group NIBU-DIBU; 1/3 of the subjects from the primary NIBU group receiving delayed ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Ibuprofen; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Nurofen for Children
Active Comparator: Group NIBU-NIBU; 1/3 of the subjects from the primary NIBU group receiving no prophylactic ibuprofen treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose
Experimental: Group IPARA-NPARA; subjects from the primary IPARA group receiving no paracetamol treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose
Experimental: Group DPARA-IPARA; subjects from the primary DPARA group receiving immediate paracetamol treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Paracetamol; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Panadol Baby
Experimental: Group NPARA-IPARA; subjects from the primary NPARA group receiving immediate paracetamol treatment after booster vaccination	Biological: GSK1024850A (SynflorixTM); Intramuscular injection, 4 doses; Biological: Infanrix hexa; Intramuscular injection, 3 doses; Biological: Infanrix-IPV/Hib; Intramuscular injection, 1 dose; Drug: Paracetamol; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Other Names: Panadol Baby

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).	One month after primary immunization (At Month 3)
Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.	One month after primary immunization (At Month 3)
Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.	One month after primary immunization (At Month 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.	One month after primary immunization (At Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).	Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).	Within the 4-day (Days 0-3) period following booster vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.	Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.	Within the 4-day (Days 0-3) period following booster vaccination
Number of Subjects With Any Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.	During the entire study period (Month 0 to 10)
Number of Subjects With Any Unsolicited Adverse Events (AEs)	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.	Within 31-days (Day 0-30) following each primary vaccination dose
Number of Subjects With Any Unsolicited Adverse Events (AEs)	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.	Within 31-days (Day 0-30) following booster vaccination
Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.	Prior to (Month 9) and one month after booster vaccination (Month 10)
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8.	One month after primary immunization (Month 3)
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes	OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value "99999.9" has been entered when value to be entered in the system was greater than (>) 1.0 E10.	Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.	Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids	Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.	One month after primary immunization (Month 3)
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids	Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.	Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.	One month after primary immunization (Month 3)
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.	Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.	One month after primary immunization (Month 3)
Antibody Concentrations Against Hepatitis B Surface Antigen	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.	Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.	One month after primary immunization (Month 3)
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)	Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.	Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Titers Against Poliovirus Type 1, 2 and 3	Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.	One month after primary immunization (Month 3)
Antibody Titers Against Poliovirus Type 1, 2 and 3	Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.	Prior to (Month 9) and one month after booster vaccination (Month 10)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Falup-Pecurariu O, Man SC, Neamtu ML, Chicin G, Baciu G, Pitic C, Cara AC, Neculau AE, Burlea M, Brinza IL, Schnell CN, Sas V, Lupu VV, Francois N, Swinnen K, Borys D. Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial. Hum Vaccin Immunother. 2017 Mar 4;13(3):649-660. doi: 10.1080/21645515.2016.1223001. Epub 2016 Aug 19.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2010
• Primary Completion (Actual): March 28, 2012
• Study Completion (Actual): December 8, 2012

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Fever; Pneumococcal vaccine; Booster vaccination; Pneumococcal disease; Primary vaccination; Prophylactic antipyretic
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 112921; 2010-019761-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 112921
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: 112921
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 112921
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 112921
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 112921
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 112921
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register