CompletedNCT00771849Updated Apr 14, 2016Results posted

Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

A Phase 2 interventional study of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate and Haemophilus Influenzae Type b (Hib) vaccine in Meningitis and Meningococcemia, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 2 sites in United Kingdom. Open to participants aged 2 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-14.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 103
Allocation: Randomized
Ages: 2 Years to 4 Years
Sex: All

Study summary

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously.

Primary objective:

To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.

Conditions studied

Meningitis
Meningococcemia

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Keywords

Meningitis
Meningococcemia
Neisseria meningitidis

In context

Diphtheria

265 studies on the registry are indexed under Diphtheria; 16 are open to participants now.

This study's enrollment of 103 is below the median of 440 across 239 interventional studies indexed under Diphtheria.

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Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 4 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Participant is healthy, as determined by medical history and physical examination.
Participant is 2 years to \< 5 years of age at the time of vaccination.
At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed.
Parent/Guardian has signed an Ethics Committee-approved informed consent form. A culturally appropriate translation will be used for non-English speaking participants where required.

Exclusion criteria

Exclusion Criteria :

Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5ºC at the time of inclusion
History of documented invasive meningococcal disease
Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrolment
Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing any blood sample
Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive any vaccine during enrolment in the trial
Received a meningococcal C conjugate vaccine within one year prior to enrolment
Suspected or known hypersensitivity to any of the vaccine components
Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
Enrolled in another clinical trial
Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 103 participants (actual)

Study arms

Experimental
Menactra® Vaccine Group
Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Active comparator
Hiberix® Vaccine Group
Participants receiving Haemophilus Influenzae Type b (Hib) vaccine
Biological: Haemophilus Influenzae Type b (Hib) vaccine

Interventions

BiologicalMeningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Also known as: Menactra®
BiologicalHaemophilus Influenzae Type b (Hib) vaccine
0.5 mL, Intramuscular
Also known as: Hiberix®

What researchers measure

Primary outcomes

Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Time frame: Day 0 (before) and 28 days post-vaccination

Secondary outcomes

Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
Time frame: 28 days post-vaccination

Results

Posted Apr 24, 2009

Participant flow

Subjects were recruited from August 2003 through March 2004 at 2 clinics in the United Kingdom.

Participant flow — Overall Study
Milestone	Menactra® Vaccine Group	Hiberix® Vaccine Group
Started	52	51
Completed	50	47
Not completed	2	4
Withdrew: Lost to follow-up	1	2
Withdrew: Withdrawal by subject	1	1
Withdrew: Not vaccinated	0	1

Outcome measures

PrimaryGeometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.

Time frame:: Day 0 (before) and 28 days post-vaccination
Reported as:: Geometric mean · Titers

Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Titers	Menactra® Vaccine Group	Hiberix® Vaccine Group
Meningococcal Serogroup A - Day 0	136.33 (69.39 to 267.84)	99.66 (47.66 to 208.40)
Meningococcal Serogroup A - Day 28	11404.16 (7383.63 to 17613.96)	199.31 (93.14 to 426.52)
Meningococcal Serogroup C - Day 0	76.11 (36.57 to 158.41)	26.91 (12.49 to 57.97)
Meningococcal Serogroup C - Day 28	12534.67 (8407.56 to 18687.71)	22.63 (10.50 to 48.76)
Meningococcal Serogroup Y - Day 0	236.61 (133.11 to 420.60)	266.05 (151.05 to 468.59)
Meningococcal Serogroup Y - Day 28	4031.98 (2399.10 to 6776.24)	298.63 (155.64 to 572.99)
Meningococcal Serogroup W-135 - Day 0	26.07 (13.30 to 51.13)	24.44 (11.76 to 50.79)
Meningococcal Serogroup W-135 - Day 28	5978.03 (3852.54 to 9276.19)	32 (16.33 to 62.71)

SecondaryParticipants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.

Time frame:: 28 days post-vaccination
Reported as:: Number · Participants

Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
Participants	Menactra® Vaccine Group	Hiberix® Vaccine Group
Meningococcal Serogroup A	43	11
Meningococcal Serogroup C	41	2
Meningococcal Serogroup Y	35	1
Meningococcal Serogroup W-135	43	8

Adverse events

Collected over Adverse events data were collected from the day of vaccination for 28 days post-vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Menactra® Vaccine Group	—	1/52 (1.9%)	15/52 (28.8%)
Hiberix® Vaccine Group	—	0/50 (0%)	22/50 (44%)

Most frequent serious events

Most frequent serious events
Event	Menactra® Vaccine Group	Hiberix® Vaccine Group
Febrile convulsionNervous system disorders	1/52	0/50

Most frequent other events

Most frequent other events
Event	Menactra® Vaccine Group	Hiberix® Vaccine Group
Upper respiratory tract infection NOSInfections and infestations	10/51	14/47
Diarrhoea NOSGastrointestinal disorders	2/51	3/47
PyrexiaGastrointestinal disorders	1/51	3/47
Gastroenteritis NOSInfections and infestations	0/51	3/47
Otitis media NOSInfections and infestations	0/51	3/47
CoughRespiratory, thoracic and mediastinal disorders	3/51	3/47

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Menactra® Vaccine Group	Hiberix® Vaccine Group	Total
<=18 years	52	51	103
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age, Continuous
Age, Continuous(Months)	Menactra® Vaccine Group	Hiberix® Vaccine Group	Total
Mean	37.0 ± 8.5	37.6 ± 8.3	37.3 ± 8.3

Sex: Female, Male
Sex: Female, Male(Participants)	Menactra® Vaccine Group	Hiberix® Vaccine Group	Total
Female	28	22	50
Male	24	29	53

Region of Enrollment
Region of Enrollment(participants)	Menactra® Vaccine Group	Hiberix® Vaccine Group	Total
United Kingdom	52	51	103

Study locations

2 sites

London, E1 1BB, United Kingdom
London, SW17 ORE, United Kingdom

References and documents

Publications

El Bashir H, Heath PT, Papa T, Ruggeberg JU, Johnson N, Sinha R, Balfour G, Booy R. Antibody responses to meningococcal (groups A, C, Y and W135) polysaccharide diphtheria toxoid conjugate vaccine in children who previously received meningococcal C conjugate vaccine. Vaccine. 2006 Mar 24;24(14):2544-9. doi: 10.1016/j.vaccine.2005.12.018. Epub 2005 Dec 27. PubMed 16417952 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00771849
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Responsible party: Sponsor
First posted: Oct 15, 2008
Start date: Aug 2003
Primary completion: Mar 2004
Completion: May 2004
Results posted: Apr 24, 2009
Last update: Apr 14, 2016

Study contacts

Medical Monitor

study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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