Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00808392

Purpose

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.

Condition	Intervention	Phase
Haemophilus Influenzae Type B	Biological: Haemophilus influenzae type b vaccine Biological: Commercial Haemophilus influenzae type b vaccine	Phase III

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA). [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	900
Study Start Date:	November 2008
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Haemophilus influenzae type b vaccine 3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
2: Active Comparator	Biological: Commercial Haemophilus influenzae type b vaccine 3 doses one month apart of Haemophilus influenzae type b vaccine.

Eligibility

Ages Eligible for Study:	2 Months to 4 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808392

Locations

China, Hebei
The CDC of Zhengding county(site no 01)	Recruiting
Zhengding, Hebei, China, 050800
Contact: Novartis Vaccines +1 800 244 7668
Principal Investigator: Novartis Vaccines
the CDC of Dingxing county(site no 02)	Recruiting
Dingxing, Hebei, China, 072650
Contact: Novartis Vaccines +1 800 244 7668
Principal Investigator: Novartis Vaccines

Sponsors and Collaborators

Novartis

Novartis Vaccines

More Information

Responsible Party:	Novartis Vaccines ( Novartis )
Study ID Numbers:	M37P2
Study First Received:	December 12, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00808392
Health Authority:	China: State Food and Drug Administration

Keywords provided by Novartis:

vaccine
prevention
haemophilus influenzae type b
children

Study placed in the following topic categories:

Virus Diseases
Haemophilus influenzae
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009