Clinical trial NCT01153841: Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Streptococcus Pneumoniae Vaccines
Keywords: Pneumococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)
timeFrame: Within the 31-day (Days 0-30) after each dose and across doses
Secondary outcomes:
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period following each dose
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period following each dose
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) follow-up period after each dose
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: After the first vaccination up to study end (From Month 0 to Month 3)
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.