Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants

Condition(s) targeted: Diphtheria, Tetanus, Pertussis, Poliomyelitis & Haemophilus Influenzae Type b Disease; Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines

Intervention: GSK Biologicals' combined DTPa-IPV/Hib vaccine (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Official title: An Open, Multicentric, Post-marketing Surveillance Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 and 18 Months of Age, in Healthy Infants.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Occurrence of solicited local and general adverse events

Secondary outcome:

Occurrence of unsolicited local and general adverse events

Occurrence of large swelling reactions

Occurrence of serious adverse events.

Detailed description: Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months

Minimum age: 11 Weeks. Maximum age: 17 Weeks. Gender(s): Both.

Criteria:

Inclusion criteria

- Subjects must have been enrolled in the Rota-028 study.

- A male or female between, and including, 11 and 17 weeks of age at the time of the

first vaccination.

- Written informed consent obtained from the parent or guardian of the subject.

- Free of obvious health problems as established by medical history and clinical

examination before entering into the study.

- Subjects for whom the investigator believes that their parents/guardians can and will

comply with the requirements of the protocol Exclusion criteria

- Chronic administration (defined as more than 14 days) of immunosuppressants or other

immune-modifying drugs during the study period.

- Planned administration/ administration of a vaccine not foreseen by the study

protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including

human immunodeficiency virus (HIV) infection.

- A family history of congenital or hereditary immunodeficiency.

- History of allergic disease or reactions likely to be exacerbated by any component of

the vaccine.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at the time of enrolment.

- Administration of immunoglobulins and/or any blood products since birth or planned

administration during the study period.

GSK Investigational Site, Singapore 308433, Singapore

Related publications:

Lim FS, Phua KB, Lee BW, Quak SH, Teoh YL, Ramakrishnan G, Han HH, Van Der Meeren O, Jacquets JM, Bock HL. Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 2011 Jan;42(1):138-47.

Starting date: November 2004
Last updated: November 8, 2012