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Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01449812
First received: October 6, 2011
Last updated: July 24, 2012
Last verified: February 2012
  Purpose

The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).


Condition Intervention Phase
Haemophilus Influenzae Type b Disease
Diphtheria
Poliomyelitis
Pertussis
Tetanus
Biological: Infanrix+Hib™
Biological: Poliorix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Persistence with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: Before the booster vaccination (Day 0) ] [ Designated as safety issue: No ]
  • Persistence with respect to components of the study vaccines in terms of antibody concentrations/titers [ Time Frame: Before the booster vaccination (Day 0) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: One month after the booster vaccination (Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines in terms of antibody concentrations/titers [ Time Frame: One month after the booster vaccination (Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines in terms of vaccine response to the pertussis antigens [ Time Frame: One month after the booster vaccination (Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following the booster dose of the study vaccine ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period following the booster dose of the study vaccine ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From Dose 1 (Day 0) up to study end (Month 1) ] [ Designated as safety issue: No ]

Enrollment: 831
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects who received Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine at 2, 3 and 4 months of age in the primary study and will receive DTPa/Hib vaccine (Infanrix Hib™) and IPV vaccine (Poliorix™) as a booster dose in the current study between 18 and 24 months of age
Biological: Infanrix+Hib™
Intramuscular, one dose
Other Name: DTPa /Hib
Biological: Poliorix™
Intramuscular, one dose
Other Name: IPV
Experimental: Group B
Subjects who received Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine at 3, 4 and 5 months of age in the primary study and will receive DTPa/Hib vaccine (Infanrix Hib™) and IPV vaccine (Poliorix™) as a booster dose in the current study between 18 and 24 months of age
Biological: Infanrix+Hib™
Intramuscular, one dose
Other Name: DTPa /Hib
Biological: Poliorix™
Intramuscular, one dose
Other Name: IPV
Active Comparator: Group C
Subjects who received the Infanrix Hib™ (DTPa/ Hib) and Poliorix™ (IPV) vaccines at 2, 3 and 4 months of age in the primary study and will receive a booster dose of the same vaccines in the current study between 18 and 24 months of age
Biological: Infanrix+Hib™
Intramuscular, one dose
Other Name: DTPa /Hib
Biological: Poliorix™
Intramuscular, one dose
Other Name: IPV

  Eligibility

Ages Eligible for Study:   18 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
  • Subjects who completed the full three-dose primary vaccination course in study NCT01086423.
  • Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Child in care
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.
  • Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423.
  • Serious chronic illness.
  • Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.
  • Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.
  • Encephalopathy
  • Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of vaccination.
  • Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
  • Seizures with or without fever occurring within 3 days of vaccination.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

  • Acute disease and/or fever at the time of enrolment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449812

Locations
China, Guangxi
GSK Investigational Site
Wuzhou, Guangxi, China, 543002
GSK Investigational Site
Wuzhou, Guangxi, China, 543100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01449812     History of Changes
Other Study ID Numbers: 114386
Study First Received: October 6, 2011
Last Updated: July 24, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
combination vaccine
booster vaccination

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014