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

NCT01153841 | Completed Phase 3 Results

• 2 other identifiers: 1131512012-000162-38
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Streptococcal; Streptococcus Pneumoniae Vaccines

Keywords

Pneumococcal vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)

  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.

  Within the 31-day (Days 0-30) after each dose and across doses

Secondary Outcomes (4)

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Days 0-3) post-vaccination period following each dose

• 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

• Number of Subjects With Unsolicited Adverse Events (AEs)

  During the 31-day (Days 0-30) follow-up period after each dose

• Number of Subjects With Serious Adverse Events (SAEs)

  After the first vaccination up to study end (From Month 0 to Month 3)

Study Arms (2)

Synflorix Group

EXPERIMENTAL

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

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

Control Group

ACTIVE COMPARATOR

Subjects receiving Infanrix hexa™ vaccine alone.

Biological: Infanrix hexa™

Interventions

Synflorix™( GSK1024850A) BIOLOGICAL

Intramuscular, 3 doses

Synflorix Group

Infanrix hexa™ BIOLOGICAL

Intramuscular, 3 doses

Control Group; Synflorix Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ho Chi Minh City, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 23432812 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Streptococcal Infections

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 30, 2010
• Study Start: February 17, 2011
• Primary Completion: July 26, 2011
• Study Completion: July 26, 2011
• Last Updated: January 2, 2020
• Results First Posted: February 27, 2017

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

VN (1)