Phase 3
Completed N=298
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
Infections, Streptococcal · Streptococcus Pneumoniae Vaccines
Source: ClinicalTrials.gov NCT01153841 ↗
Enrolled (actual)
298
Serious AEs
5.0%
Results posted
Feb 2017
Primary outcomePrimary: Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) — 24; 3; 18; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) |
24; 3; 18; 3; 6; 3 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms |
116; 34; 22; 1; 48; 13 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms |
75; 19; 3; 0; 60; 15 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
57; 37 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
9; 6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01153841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.