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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Streptococcus Pneumoniae Vaccines; Infections, Streptococcal

Treatments: Biological: Infanrix hexa™; Biological: Synflorix™( GSK1024850A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01153841

2012-000162-38 (EudraCT Number)

113151

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Synflorix Group

Experimental group

Description:

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

Treatment:

Biological: Infanrix hexa™

Biological: Synflorix™( GSK1024850A)

Control Group

Active Comparator group

Description:

Subjects receiving Infanrix hexa™ vaccine alone.

Treatment:

Biological: Infanrix hexa™