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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-17

Study Completion Date

2011-07-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections, Streptococcal Streptococcus Pneumoniae Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Synflorix Group

Subjects receiving Synflorix™(GSK 1024850A) co-administered along with Infanrix hexa™.

Group Type EXPERIMENTAL

Synflorix™( GSK1024850A)

Intervention Type BIOLOGICAL

Intramuscular, 3 doses

Infanrix hexa™

Intervention Type BIOLOGICAL

Intramuscular, 3 doses

Control Group

Subjects receiving Infanrix hexa™ vaccine alone.

Group Type ACTIVE_COMPARATOR

Infanrix hexa™

Intervention Type BIOLOGICAL

Intramuscular, 3 doses

Interventions

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Synflorix™( GSK1024850A)

Intramuscular, 3 doses

Intervention Type BIOLOGICAL

Infanrix hexa™

Intramuscular, 3 doses

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

References

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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.

Reference Type BACKGROUND

PMID: 23432812 (View on PubMed)

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.

Reference Type BACKGROUND

Study Documents

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