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

NCT00808392 | Completed Phase 3

• 1 other identifier: M37P2
• Study Type: interventional
• Target: 916
• Locations: 1 country
• Sites: 2

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.

Conditions

Haemophilus Influenzae Type b

Keywords

vaccine; prevention; haemophilus influenzae type b; children

Outcome Measures

Primary Outcomes (1)

• Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).

  90 days

Secondary Outcomes (1)

• Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.

  90 days

Study Arms (2)

1

EXPERIMENTAL

Biological: Haemophilus influenzae type b vaccine

2

ACTIVE COMPARATOR

Biological: Commercial Haemophilus influenzae type b vaccine

Interventions

Haemophilus influenzae type b vaccine BIOLOGICAL

3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine

1

Commercial Haemophilus influenzae type b vaccine BIOLOGICAL

3 doses one month apart of Haemophilus influenzae type b vaccine.

2

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (2)

the CDC of Dingxing county(site no 02)

Dingxing, Hebei, 072650, China

Location

The CDC of Zhengding county(site no 01)

Zhengding, Hebei, 050800, China

Location

MeSH Terms

Conditions

Haemophilus Infections

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 29, 2011

Record last verified: 2011-12

Locations

CN (2)