- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00808392
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
December 26, 2011 updated by: Novartis Vaccines
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
Study Type
Interventional
Enrollment (Actual)
916
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
|
Active Comparator: 2
|
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).
Time Frame: 90 days
|
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.
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Haemophilus Influenzae Type b
-
GlaxoSmithKlineCompletedHaemophilus Influenzae Type b DiseaseChina
-
Public Health EnglandCompletedHaemophilus Influenzae Type b
-
GlaxoSmithKlineCompletedHib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate VaccinesNeisseria Meningitidis | Haemophilus Influenzae Type bAustralia
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited Kingdom
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain, Germany, Poland
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bAustralia
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
Clinical Trials on Haemophilus influenzae type b vaccine
-
Novartis VaccinesCompletedHaemophilus Influenzae Type b (Hib) InfectionChina
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bPoland, United Kingdom
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain
-
Novartis VaccinesCompletedHaemophilus Influenzae Type bChina
-
Novartis VaccinesCompletedHaemophilus Influenzae Type b (Hib) InfectionChina
-
Novartis VaccinesCompletedHaemophilus Influenzae Type b (Hib) InfectionChina
-
Novartis VaccinesCompletedHaemophilus Influenzae Type b (Hib) InfectionChina
-
Sanofi Pasteur, a Sanofi CompanyCompletedMeningitis | MeningococcemiaUnited Kingdom
-
Sanofi Pasteur, a Sanofi CompanyCompletedStudy of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian InfantsHepatitis B | Pertussis | Tetanus | Diphtheria | Haemophilus Influenzae Type bPeru