- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368966
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
July 6, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations in Spain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
619
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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A Coruna, Spain, 15006
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Almeria, Spain, 04120
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Almeria, Spain, 04009
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Almeria, Spain, 04007
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Barcelona, Spain, 08025
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Barcelona, Spain, 08017
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La Coruna, Spain, 15270
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Madrid, Spain, 28041
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Madrid, Spain, 28021
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Malaga, Spain, 29015
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Ourense, Spain, 32005
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Sevilla, Spain, 41013
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Valencia, Spain, 46008
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Valencia, Spain, 46011
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Valencia, Spain, 46021
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Valencia, Spain, 46022
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Valencia, Spain, 46023
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Valencia, Spain, 46024
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Valencia, Spain, 46200
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Valencia, Spain, 46013
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A Coruna
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Ferrol, A Coruna, Spain, 15405
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Santiago de Compostela, A Coruna, Spain, 15706
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Barcelona
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Argentona, Barcelona, Spain, 08310
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Sabadell, Barcelona, Spain, 08208
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Sant Adria de Besos, Barcelona, Spain, 08930
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Sant Cugat del Valles, Barcelona, Spain, 08195
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Sant Cugat del Valles, Barcelona, Spain, 08197
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Bizkaia
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Bilbao, Bizkaia, Spain, 48013
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Lugo
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Burela, Lugo, Spain, 27880
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Madrid
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Alcorcon, Madrid, Spain, 28922
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Fuenlabrada, Madrid, Spain, 28943
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Getafe, Madrid, Spain, 28902
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Getafe, Madrid, Spain, 28900
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Mostoles, Madrid, Spain, 28937
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Parla, Madrid, Spain, 28980
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Malaga
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Antequera, Malaga, Spain, 29200
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Navarra
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Pamplona, Navarra, Spain, 31008
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Pontevedra
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Vigo, Pontevedra, Spain, 36204
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Valencia
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Burjassot, Valencia, Spain, 46110
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La Eliana, Valencia, Spain, 46183
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Quart de Poblet, Valencia, Spain, 46930
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 3 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy 2-month-old infants
- Available for the entire study period
Exclusion criteria:
- Previous vaccination with any vaccine before the start of the study
- Known contraindication to vaccination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Active Comparator: 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Time Frame: One month after 2-doses of the infant series (5 months of age)
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Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01
International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.
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One month after 2-doses of the infant series (5 months of age)
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Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Time Frame: One month after 2-doses of the infant series (5 months of age)
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One month after 2-doses of the infant series (5 months of age)
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Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Time Frame: One month after 2-doses of the infant series (5 months of age)
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One month after 2-doses of the infant series (5 months of age)
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Percentage of Participants Reporting Pre-Specified Local Reactions
Time Frame: During the 4-day period after each dose
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Local reactions were collected using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement).
Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm).
Participants may be represented in more than 1 category.
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During the 4-day period after each dose
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Percentage of Participants Reporting Pre-Specified Systemic Events
Time Frame: During the 4-day period after each dose
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Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary.
Participants may be represented in more than 1 category.
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During the 4-day period after each dose
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Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
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One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.
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One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.
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One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)
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Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
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One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Trial Manager, For Spain, infomed@wyeth.com
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
- Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
August 25, 2006
First Submitted That Met QC Criteria
August 25, 2006
First Posted (Estimate)
August 29, 2006
Study Record Updates
Last Update Posted (Estimate)
August 16, 2012
Last Update Submitted That Met QC Criteria
July 6, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6096A1-501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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