Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam

Primary Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, in Healthy Infants in Vietnam When Co-administered With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.

Study Overview

• Status: Completed
• Conditions: Streptococcus Pneumoniae Vaccines; Infections, Streptococcal
• Intervention / Treatment: Biological: Synflorix™( GSK1024850A); Biological: Infanrix hexa™

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• Written and signed or thumb-printed informed consent obtained from the parent(s)/LAR of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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.
• Acute disease and/or fever at the time of enrolment.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
• Hypersensitivity to latex.
• Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine is administered. Other locally recommended vaccines are allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synflorix Group; Subjects receiving Synflorix™(GSK 1024850A) co-administered along with Infanrix hexa™.	Biological: Synflorix™( GSK1024850A); Intramuscular, 3 doses; Biological: Infanrix hexa™; Intramuscular, 3 doses
Active Comparator: Control Group; Subjects receiving Infanrix hexa™ vaccine alone.	Biological: Infanrix hexa™; Intramuscular, 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)	The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.	Within the 31-day (Days 0-30) after each dose and across doses

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.	During the 4-day (Days 0-3) post-vaccination period following each dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms	Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.	During the 4-day (Days 0-3) post-vaccination period following each dose
Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.	During the 31-day (Days 0-30) follow-up period after each dose
Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	After the first vaccination up to study end (From Month 0 to Month 3)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Huu TN, Toan NT, Tuan HM, Viet HL, Le Thanh Binh P, Yu TW, Shafi F, Habib A, Borys D. Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial. BMC Infect Dis. 2013 Feb 21;13:95. doi: 10.1186/1471-2334-13-95.
• Tran NH et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants. Abstract presented at the ICID, Bangkok, Thailand, June 13-16, 2012.

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): February 17, 2011
• Primary Completion (Actual): July 26, 2011
• Study Completion (Actual): July 26, 2011

Study Registration Dates

• First Submitted: June 17, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Pneumococcal vaccine
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal; Streptococcal Infections
• Other Study ID Numbers: 113151; 2012-000162-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Clinical Study Report
   Information identifier: 113151
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 113151
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 113151
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 113151
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 113151
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 113151
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register