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

NCT00325156 | Completed Phase 4 Results

• 2 other identifiers: 1009172015-001512-35
• Study Type: interventional
• Target: 2,590
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting Any Solicited Local and General Symptoms

  Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )\], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.

  During the 4-day (Days 0-3) post-vaccination period, across doses

Secondary Outcomes (3)

• Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)

  During the 30-day (Days 0-29) post-vaccination period

• Number of Subjects Reporting Large Injection Site Swelling

  At Month 18, post-booster dose

• Number of Subjects Reporting Any Serious Adverse Events (SAEs)

  During the entire study period

Study Arms (1)

Group A

EXPERIMENTAL

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

Interventions

GSK Biologicals' combined DTPa-IPV/Hib vaccine BIOLOGICAL

4 intramuscular injections

Group A

Eligibility Criteria

• Age: 11 Weeks - 17 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Singapore, 308433, Singapore

Location

Related Publications (1)

• 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.

  PMID: 21323176 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

Diphtheria; Tetanus; Poliomyelitis; Haemophilus Infections

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Limitations and Caveats

None reported.

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 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2006
• First Posted: May 12, 2006
• Study Start: November 2, 2004
• Primary Completion: August 23, 2007
• Study Completion: August 23, 2007
• Last Updated: January 2, 2020
• Results First Posted: February 7, 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

SG (1)