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Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

A Randomized, Open-Label Trial of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

NCT00161928•Pfizer

View on ClinicalTrials.gov

Summary

The primary aim of the study is to show that NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in infants.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male and female volunteers infants, aged 2 to 6 months
•Clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal C vaccine outside the scope of a clinical trial)
•Parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation
•Parent(s)/legal guardian and infant will be available for the duration of the study

Exclusion Criteria

•History of any vaccine-related contraindicating event (e.g. anaphylaxis)
•Rash or other dermatological condition at the injection site which could interfere with injection site reaction monitoring or lead to a dermatological reaction
•Subjects who have received or will receive other vaccine(s) ± 30 days before or after the study period
•Concurrent participation in or previous participation in a clinical trial with an investigational medicinal product
•Subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
•Subjects who have previously received a vaccination against Hep B or meningococcal C
•Subjects who have received banked human blood or immunoglobulins within one month of study entry

Locations (14)

Freistädter Strasse 290

Linz, Austria

Grieskirchner Strasse 17

Wels, Austria

Neuschwansteinstrasse 5

Augsburg, Germany

Marktplatz 3

Bad Saulgau, Germany

Hasenheide 66

Berlin, Germany

Hauptstrasse 9

Bietigheim-Bissingen, Germany

Rheinstrasse13

Ettenheim, Germany

Solothurner Strasse 2

Heilbronn, Germany

Haupstrasse 240

Kehl, Germany

Löpsinger Strasse 8

Nördlingen, Germany

Key Dates

Start Date

April 1, 2002

Completion Date

January 1, 2003

Last Updated

May 21, 2015

Enrollment

330

Estimated participants

Conditions

Meningitis, Meningococcal

Interventions

Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)

BIOLOGICAL

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

NCT05252715

Meningitis, Meningococcal

View study

TERMINATEDNA

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

NCT03549325

Meningitis, Meningococcal

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COMPLETEDPHASE4

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

Inclusion Criteria

Exclusion Criteria

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants