Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age
2 other identifiers
interventional
601
2 countries
3
Brief Summary
The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2004
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 2, 2005
CompletedFirst Posted
Study publicly available on registry
December 6, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedResults Posted
Study results publicly available
June 18, 2014
CompletedJune 18, 2014
June 1, 2014
10 months
December 2, 2005
September 2, 2013
June 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.
Baseline and at 1 month after the 3 dose primary vaccination series
Secondary Outcomes (21)
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Baseline and 1 month after the 3 dose primary vaccination series
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Baseline and 1 month after the 3 dose primary vaccination series
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Baseline and 1 month after second vaccination
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Baseline and 1 month after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
at 12 months of age and 1 month after booster vaccination
- +16 more secondary outcomes
Study Arms (7)
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
EXPERIMENTALThree doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age in the UK group. A fourth dose of MenACWY Ad+ was given at 12 months of age.
UK24+ (MenACWY Ad+ at 2, 4 m)
EXPERIMENTALTwo doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
UKMenC (Menjugate at 2, 4 m)
EXPERIMENTALTwo doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
EXPERIMENTALThree doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age of the Canadian group (Prevnar at 6 months was optional and was given if available).One subgroup of subjects was given a reduced dose (1/5) of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24+ (MenACWY Ad+ at 2, 4 m)
EXPERIMENTALTwo doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (1/5) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
EXPERIMENTALTwo doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
EXPERIMENTALTwo doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Interventions
MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
Prevnar was administered IM in the anterolateral area of the left thigh.
MMR at 12 month of age, administered in the left arm.
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Menjugate was injected IM in the anterolateral area of the right thigh.
Eligibility Criteria
You may qualify if:
- Individuals eligible for enrollment in this study were male, and female infants:
- Who were healthy 2-month old infants (55-89 days, inclusive) born after full term pregnancy with an estimated gestational age ≥ 37 weeks, and a birth weight ≥ 2.5 kg;
- For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
- Who were available for all the visits scheduled in the study;
- Who were in good health as determined by:
- Medical history;
- Physical examination;
- Clinical judgment of the investigator.
You may not qualify if:
- Ineligible for the study were infants:
- Whose parents/legal guardians were unwilling, or unable to give written informed consent for the subject to participate in the study;
- Who previously received any meningococcal vaccine;
- Who received prior vaccination with D, T, P (acellular, or whole cell), IPV, or OPV, HBV, H influenzae type b (Hib), or Pneumococcus;
- Who had a previously ascertained or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus, or B pertussis (history of laboratory-confirmed or clinical condition of spasmodic cough for a period ≥ 2 weeks associated with apnea or whooping cough);
- Who had household contact with and/or intimate exposure to an individual with laboratory-confirmed N meningitis (serogroups A, C, W-135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection since birth;
- Who had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or known hypersensitivity to any vaccine component;
- Who had experienced significant acute or chronic infection within the previous 7 days, or fever (≥ 38.0°C) within the previous 3 days;
- Who had any present, or suspected serious, acute (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition, or insulin-dependent diabetes); or progressive neurological disease; or a genetic anomaly or known cytogenic disorders (e.g., Downs syndrome);
- Who had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
- receipt of any immunosuppressive therapy since birth;
- receipt of immunostimulant since birth;
- receipt of any systemic corticosteroid since birth.
- Who had a suspected or known HIV infection, or HIV-related disease;
- Who had ever received blood, blood products and/or plasma derivatives, or any parenteral immunoglobulin preparation;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Vaccineslead
- Novartiscollaborator
Study Sites (3)
Vaccine Evaluation Center
Vancouver, British Columbia, Canada
Clinical Trial Research Center
Halifax, Nova Scotia, Canada
Oxford Vaccine Group
Oxford, United Kingdom
Related Publications (2)
Snape MD, Perrett KP, Ford KJ, John TM, Pace D, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):173-84. doi: 10.1001/jama.2007.29-c.
PMID: 18182599RESULTPerrett KP, Snape MD, Ford KJ, John TM, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. Pediatr Infect Dis J. 2009 Mar;28(3):186-93. doi: 10.1097/INF.0b013e31818e037d.
PMID: 19209097RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccine and Diagnostics S.r.l
Study Officials
- STUDY DIRECTOR
Novartis Vaccines
Novartis Vaccines & Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2005
First Posted
December 6, 2005
Study Start
September 1, 2004
Primary Completion
July 1, 2005
Study Completion
October 1, 2006
Last Updated
June 18, 2014
Results First Posted
June 18, 2014
Record last verified: 2014-06