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

Phase 3

Completed

• Conditions: Haemophilus Influenzae Type b
• Interventions: Biological: Haemophilus influenzae type b vaccine; Biological: Commercial Haemophilus influenzae type b vaccine

• Registration Number: NCT00808392
• Lead Sponsor: Novartis Vaccines

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-26
• Last Update Posted: 2011-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 916

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Haemophilus influenzae type b vaccine	-
2	Commercial Haemophilus influenzae type b vaccine	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

the CDC of Dingxing county(site no 02); 🇨🇳 Dingxing, Hebei, China

The CDC of Zhengding county(site no 01); 🇨🇳 Zhengding, Hebei, China