Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
NCT ID: NCT00262002
Last Updated: 2014-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
601 participants
INTERVENTIONAL
2004-09-30
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three 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.
MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
UK24+ (MenACWY Ad+ at 2, 4 m)
Two 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.
MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
UKMenC (Menjugate at 2, 4 m)
Two 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.
MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Menjugate (Men C conjugated vaccine)
Menjugate was injected IM in the anterolateral area of the right thigh.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three 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.
MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
HBV (Hepatitis B vaccine)
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Prevnar was administered IM in the anterolateral area of the left thigh.
MMR (Measles, Mumps and Rubella vaccine)
MMR at 12 month of age, administered in the left arm.
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
CA24+ (MenACWY Ad+ at 2, 4 m)
Two 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.
MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
HBV (Hepatitis B vaccine)
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Prevnar was administered IM in the anterolateral area of the left thigh.
MMR (Measles, Mumps and Rubella vaccine)
MMR at 12 month of age, administered in the left arm.
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
UK24- (MenACWY Ad- at 2, 4 m)
Two 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.
MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
CA24- (MenACWY Ad- at 2, 4 m)
Two 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.
MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.
MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
HBV (Hepatitis B vaccine)
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Prevnar was administered IM in the anterolateral area of the left thigh.
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Interventions
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MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.
MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
HBV (Hepatitis B vaccine)
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Prevnar was administered IM in the anterolateral area of the left thigh.
MMR (Measles, Mumps and Rubella vaccine)
MMR at 12 month of age, administered in the left arm.
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Menjugate (Men C conjugated vaccine)
Menjugate was injected IM in the anterolateral area of the right thigh.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* Who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
* Who had a history of seizure disorder:
* Febrile seizure;
* Any other seizure disorder.
* Who had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who received an oral or parenteral β-lactam antibiotic \[examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.\] may be enrolled 7 days following the last dose);
* Who with their parents/legal guardians were planning to leave the area of the study site before the end of the study period;
* Who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
* Who had taken any antipyretic medication in the previous 6 hours.
2 Months
6 Months
ALL
Yes
Sponsors
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Novartis
INDUSTRY
Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_DIRECTOR
Novartis Vaccines & Diagnostics
Locations
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Vaccine Evaluation Center
Vancouver, British Columbia, Canada
Clinical Trial Research Center
Halifax, Nova Scotia, Canada
Oxford Vaccine Group
Oxford, , United Kingdom
Countries
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References
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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.
Perrett 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.
Other Identifiers
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2004-000195-13
Identifier Type: -
Identifier Source: secondary_id
V59P5
Identifier Type: -
Identifier Source: org_study_id
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