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

Phase 3

Completed

Conditions: Infections, Streptococcal
Streptococcus Pneumoniae Vaccines

Interventions: Biological: Infanrix hexa™
Biological: Synflorix™( GSK1024850A)

Registration Number: NCT01153841

Lead Sponsor: GlaxoSmithKline

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Infanrix hexa™	Subjects receiving Infanrix hexa™ vaccine alone.
Synflorix Group	Infanrix hexa™	Subjects receiving Synflorix™(GSK 1024850A) co-administered along with Infanrix hexa™.
Synflorix Group	Synflorix™( GSK1024850A)	Subjects receiving Synflorix™(GSK 1024850A) co-administered along with Infanrix hexa™.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)	Within the 31-day (Days 0-30) after each dose and across doses	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms	During the 4-day (Days 0-3) post-vaccination period following each dose	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.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms	During the 4-day (Days 0-3) post-vaccination period following each dose	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.
Number of Subjects With Unsolicited Adverse Events (AEs)	During the 31-day (Days 0-30) follow-up period after each dose	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.
Number of Subjects With Serious Adverse Events (SAEs)	After the first vaccination up to study end (From Month 0 to Month 3)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.