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

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ClinicalTrials.gov Identifier: NCT00325156

Recruitment Status : Completed

First Posted : May 12, 2006

Results First Posted : February 7, 2017

Last Update Posted : January 2, 2020

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diphtheria Tetanus Poliomyelitis Acellular Pertussis Haemophilus Influenzae Type b Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines	Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine	Phase 4

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2590 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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.
Actual Study Start Date :	November 2, 2004
Actual Primary Completion Date :	August 23, 2007
Actual Study Completion Date :	August 23, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Haemophilus Infections Vaccines

Genetic and Rare Diseases Information Center resources: Whooping Cough Tetanus Poliomyelitis Diphtheria Haemophilus Influenzae Myelitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A	Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine 4 intramuscular injections

Outcome Measures

Primary Outcome Measures :

Number of Subjects Reporting Any Solicited Local and General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period, across doses ]
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.

Secondary Outcome Measures :

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects Reporting Large Injection Site Swelling [ Time Frame: At Month 18, post-booster dose ]
A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.
Number of Subjects Reporting Any Serious Adverse Events (SAEs) [ Time Frame: During the entire study period ]
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

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Ages Eligible for Study:	11 Weeks to 17 Weeks (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325156

Locations

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Singapore
GSK Investigational Site
Singapore, Singapore, 308433

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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