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NCT Number: NCT00345579

Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.

This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

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Key information

Conditions

Haemophilus Influenzae Type b Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Infections Neisseria Meningitidis Pasteurellaceae Infections

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Mexico City, Mexico

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About this study

Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after 36 weeks gestation.
  • Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
  • Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Exclusion criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
  • Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
  • History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Concurrent participation 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 (pharmaceutical product or device).

Treatment and study plan

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014

Biological

3-dose intramuscular injection

ActHIB

Biological

3-dose intramuscular injection

Pediarix/Infanrix Penta

Biological

3-dose intramuscular injection

Primary outcomes

  1. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  2. Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)

    Time frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  3. Number of Subjects Reporting Rash

    Time frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

  4. Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)

    Time frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

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

    Time frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  6. Number of Subjects With New Onset of Chronic Illnesses (NOCIs)

    Time frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  7. Number of Subjects With Rash

    Time frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae

  8. Number of Subjects With Adverse Events Resulting in Emergency Room (ER)

    Time frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 28, 2006
Registry last updated
Dec 16, 2016

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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