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

NCT00734565 | Completed Phase 1

• 1 other identifier: M37P1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate safety and reactogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children

Conditions

Haemophilus Influenzae Type b

Keywords

vaccine; prevention; haemophilus influenzae type b; children

Outcome Measures

Primary Outcomes (1)

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

  30 days

Secondary Outcomes (1)

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

  90 days

Study Arms (1)

1

EXPERIMENTAL

Biological: Haemophilus influenzae type b

Interventions

Haemophilus influenzae type b BIOLOGICAL

1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months

1

Eligibility Criteria

• Age: 2 Months - 20 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants of either sex, aged 16 - 20 months / 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;
• written informed consent 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 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;
• infants who have received any other Haemophilus influenzae type b immunization dose before (for 16-20 months old children who have received a booster vaccination already);
• 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) and/or 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;
• treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months);
• any vaccination administered within 2 weeks (14 days) before enrollment;
• participation in any other investigational trial simultaneously;

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Vaccination site

Shijiazhuang, 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 Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 8, 2012

Record last verified: 2012-02

Locations

CN (1)