Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine

NCT01086423 | Completed Phase 3 Results

• 1 other identifier: 112584
• Study Type: interventional
• Target: 985
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Conditions

Tetanus; Poliomyelitis; Acellular Pertussis; Diphtheria; Haemophilus Influenzae Type b

Keywords

Infanrix-IPV+Hib

Outcome Measures

Primary Outcomes (4)

• Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens

  A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  One month after the third vaccine dose (Month 3 or Month 4)

• Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen

  A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).

  One month after the third vaccine dose (Month 3 or Month 4)

• Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens

  A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.

  One month after the third vaccine dose (Month 3 or Month 4)

• Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens

  Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects \[antibody concentration lower than (\<) 5 EL.U/mL\], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.

  One month after the third vaccine dose (Month 3 or Month 4)

Secondary Outcomes (8)

• Anti-D and Anti-T Antibody Concentrations

  Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)

• Anti-PRP Antibody Concentrations

  Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

• Anti-polio Types 1, 2 and 3 Antibody Titers

  Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

• Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

  Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

• Number of Subjects With Any Solicited Local Symptoms

  During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses

Study Arms (3)

INFANRIX-IPV+HIB 1 GROUP

EXPERIMENTAL

Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.

Biological: Infanrix-IPV/Hib™

INFANRIX-IPV+HIB 2 GROUP

EXPERIMENTAL

Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.

Biological: Infanrix-IPV/Hib™

INFANRIX-HIB+POLIORIX GROUP

ACTIVE COMPARATOR

Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.

Biological: Infanrix Hib™; Biological: Poliorix™

Interventions

Infanrix-IPV/Hib™ BIOLOGICAL

Intramuscular, three doses

INFANRIX-IPV+HIB 1 GROUP; INFANRIX-IPV+HIB 2 GROUP

Infanrix Hib™ BIOLOGICAL

Intramuscular, three doses

INFANRIX-HIB+POLIORIX GROUP

Poliorix™ BIOLOGICAL

Intramuscular, three doses

INFANRIX-HIB+POLIORIX GROUP

Eligibility Criteria

• Age: 60 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
• Born after a gestation period of 36 to 42 weeks, inclusive.
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s) or LAR(s) of the subject.
• Healthy subjects 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.
• Child in care.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
• 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.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Haemophilus influenzae type b (Hib) disease or vaccination.
• History of seizures or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• Current febrile illness or axillary temperature \> 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Wuzhou, Guangxi, 543002, China

Location

GSK Investigational Site

Wuzhou, Guangxi, 543100, China

Location

MeSH Terms

Conditions

Tetanus; Poliomyelitis; Diphtheria; Haemophilus Infections

Interventions

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

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; 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; Corynebacterium Infections; Actinomycetales Infections; Pasteurellaceae Infections; Gram-Negative Bacterial 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: March 11, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: November 19, 2010
• Study Completion: November 19, 2010
• Last Updated: June 6, 2018
• Results First Posted: April 10, 2017

Record last verified: 2017-04

Locations

CN (2)