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Completed

NCT Number: NCT01086423

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

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.

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Key information

Conditions

Tetanus Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Corynebacterium Infections Diphtheria Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Picornaviridae Infections Poliomyelitis RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

60 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Wuzhou, Guangxi, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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

  • Current febrile illness or axillary temperature > 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.

Treatment and study plan

Infanrix-IPV/Hib™

Biological

Intramuscular, three doses

Infanrix Hib™

Biological

Intramuscular, three doses

Poliorix™

Biological

Intramuscular, three doses

Primary outcomes

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

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

    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).

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

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

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

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

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

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

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

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

    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.

Secondary outcomes

  1. Anti-D and Anti-T Antibody Concentrations

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

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

  2. Anti-PRP Antibody Concentrations

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

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

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

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

    Antibody titers were presented as geometric mean titers (GMTs).

  4. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

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

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  5. Number of Subjects With Any Solicited Local Symptoms

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

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

  6. Number of Subjects With Any Solicited General Symptoms

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

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.

  7. Number of Subjects With Unsolicited Adverse Events (AEs)

    Time frame: During the 31-day (Days 0-30) post-vaccination period after any dose

    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.

  8. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: During the entire study period (from Month 0 to Month 4/5)

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 15, 2010
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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