Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart

This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.

Study Overview

• Status: Completed
• Conditions: Haemophilus Influenzae Type b
• Intervention / Treatment: Biological: Haemophilus influenzae type b vaccine; Biological: Commercial Haemophilus influenzae type b vaccine

• Study Type: Interventional
• Enrollment (Actual): 916
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hebei
    • Dingxing, Hebei, China, 072650
      • the CDC of Dingxing county(site no 02)
    • Zhengding, Hebei, China, 050800
      • The CDC of Zhengding county(site no 01)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 4 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants of either sex, aged 2 - 4 months

• In good health as determined by:

  • medical history
  • physical examination
  • clinical judgment of the investigator;
• Available for all visits scheduled in the study and able to comply with all study regulations
• For whom written informed consent has been obtained from at least one parent or legal guardian

Exclusion Criteria:

• Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
• Infants who have received any other Haemophilus influenzae type b immunization dose before
• Infants who presented a previous disease potentially related to Haemophilus influenzae type b
• Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
• Premature (before 37th week of gestation) or birth weight less than 2500 g
• History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
• Fever ≥ 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment
• Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease
• Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
• Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder
• Subjects with a clinically significant genetic anomaly
• Treatment with corticosteroids or other immunosuppressive drugs
• Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
• Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
• Participation in any other investigational trial simultaneously
• Planned surgery during the study period
• Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: Haemophilus influenzae type b vaccine; 3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
Active Comparator: 2	Biological: Commercial Haemophilus influenzae type b vaccine; 3 doses one month apart of Haemophilus influenzae type b vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.	90 days

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 12, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 29, 2011
• Last Update Submitted That Met QC Criteria: December 26, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: vaccine; children; prevention; haemophilus influenzae type b
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Orthomyxoviridae Infections; Pasteurellaceae Infections; Influenza, Human; Haemophilus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: M37P2