Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age

June 14, 2011 updated by: Dalhousie University

Safety and Immunogenicity of Two Mixed Primary Immunization Schedules: Pediacel® at 2 and 4 Months of Age Followed by One Dose of Infanrix™ IPV/Hib at 6 Months of Age; and, Infanrix™ IPV/Hib at 2 Months of Age, Followed by Pediacel® at 4 and 6 Months of Age

To demonstrate the safety and immunogenicity of two mixed primary immunization schedules: Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of age; and, Infanrix™ IPV/Hib at 2 months of age, followed by Pediacel® at 4 and 6 months of age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Immunogenicity will be evaluated using the following:

Serological outcome measures will be assessed on day 0 (visit 1) and 28-42 days after the 3rd dose of the primary series for both groups:

  • Seroprotection rates for antibodies against PRP (anti-PRP), defined as percentage of subjects with antibody concentrations ≥ 0.15 µg/ml and ≥ 1.0 µg/ml.
  • Geometric mean concentration (GMC) for antibodies against PT, FHA, PRN, and FIM.
  • Anti-pertussis antibody concentrations ≥4-fold rise (post-Dose 3/pre-Dose 1).

Safety will be evaluated using the following:

  • Occurrence, time to onset, number of days of occurrence, severity and seriousness of solicited injection site reactions (tenderness, erythema, swelling) and systemic symptoms (fever, vomiting, crying abnormal, drowsiness, appetite decreased, irritability) within 8 days (Day 0 - Day 7) after each vaccination and across all vaccinations.
  • Occurrence, nature, time to onset, duration, severity, and relationship to vaccination of unsolicited adverse events (AE) occurring within 31 days (Day 0 -Day 30) of each vaccination.
  • Occurrence, nature, time to onset, duration, and relationship to vaccination of any serious adverse events (SAE) during the entire study period for all groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
253

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Canadian Center for Vaccinology
    • Quebec
      • Pierrefonds, Quebec, Canada, H9H 4Y6
        • MUHC- Vaccine Study Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Infants aged 6 wks (42 days) to 2 months (1 day before they turn 3 months) inclusive on the day of inclusion.
  2. Born at full term of pregnancy (defined as ≥37 weeks, 0 days).
  3. Informed consent form signed by the parent(s) or legally authorized representative.
  4. Able to attend all scheduled visits and to comply with the study procedures.
  5. Parent or legally authorized representative has access to a telephone.
  6. Parent or legally authorized representative able to read and write in English or French.

Exclusion Criteria:

  1. Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  2. Planned participation in another clinical trial during the present trial period.
  3. Personal history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
  4. Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).
  5. Chronic illness that could interfere with trial conduct or completion.
  6. Received blood or blood-derived products since birth.
  7. Any vaccination preceding the first trial vaccination, except vaccinations recommended as part of the infant schedule.
  8. Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis-DTwP) based combination vaccines, Haemophilus influenzae type b Hib)conjugate,or poliovirus vaccines.
  9. Coagulation disorder contraindicating intramuscular vaccination.
  10. Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
  11. Developmental delay or neurological disorder.
  12. Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
  13. History of Hib, diphtheria, tetanus, pertussis or poliovirus disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1
Pediacel® at 2 and 4 months of age followed by Infanrix™-IPV/Hib at 6 months.
Biological: Pediacel® and Infanrix™-IPV/Hib
0.5 mL IM at 2,4 and 6 months of age
Active Comparator: Group 2
Infanrix™-IPV/Hib at 2 months of age followed by Pediacel® at 4 and 6 months.
Biological: Pediacel® and Infanrix™-IPV/Hib
0.5 mL IM at 2,4 and 6 months of age

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Descriptive statistics will be used to summarize the safety and immunogenicity of the two mixed primary immunization schedules.
Time Frame: serology at 2 and 7 months of age
serology at 2 and 7 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dalhousie University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IWK Health Centre
MCM Vaccines B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joanne Langley, MD, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP91

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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