B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

NCT ID: NCT00488683

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-06-30

Brief Summary

This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age

Conditions

Meningococcal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MenACWY-CRM and Routine Vaccines (Group 1)

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.

DTaP-Hib-IPV

Intervention Type: BIOLOGICAL

IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.

PCV

Intervention Type: BIOLOGICAL

IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.

MMR

Intervention Type: BIOLOGICAL

IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.

Hib

Intervention Type: BIOLOGICAL

IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.

MenACWY-CRM and Routine Vaccines (Group 2)

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.

This group had an additional blood draw at the time of enrollment.

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.

DTaP-Hib-IPV

Intervention Type: BIOLOGICAL

IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.

PCV

Intervention Type: BIOLOGICAL

IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.

MMR

Intervention Type: BIOLOGICAL

IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.

Hib

Intervention Type: BIOLOGICAL

IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.

MenACWY-CRM and Routine Vaccines (Group 3)

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.

This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM.

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.

DTaP-Hib-IPV

Intervention Type: BIOLOGICAL

IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.

PCV

Intervention Type: BIOLOGICAL

IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.

MMR

Intervention Type: BIOLOGICAL

IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.

Hib

Intervention Type: BIOLOGICAL

IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.

Interventions

MenACWY-CRM

One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.

Intervention Type: BIOLOGICAL

DTaP-Hib-IPV

IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.

Intervention Type: BIOLOGICAL

PCV

IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.

Intervention Type: BIOLOGICAL

MMR

IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.

Intervention Type: BIOLOGICAL

Hib

IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.

Intervention Type: BIOLOGICAL

Other Intervention Names

Combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine; Pediacel; Heptavalent Streptoccus pneumonia; Prevnar; Measles, mumps, and rubella vaccine; Priorix; Vaxem Hib

Eligibility Criteria

Inclusion Criteria

Subjects who were eligible to be enrolled in the study:

• healthy infants aged 2 months (56 - 83 days old, inclusive);
• available for the visits scheduled in the study;
• mother available for blood draw at Visit 1;
• good health as determined by the clinical judgement of the investigator;
• whose parents gave written informed consent for the infant to be enrolled in the study. The infant's parents must have been willing for the infant to receive the full primary immunization course.

Exclusion Criteria

Subjects who were not eligible for the study were those:

• whose parents had not given or were unwilling or unable to give written informed consent to their child's participation in the study
• with known hypersensitivity to any vaccines contained within the routine immunization schedule
• with unacceptable concurrent illnesses or conditions - e.g.:

1. a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;

2. a genetic anomaly, e.g. Down's syndrome;

3. any immunodeficiency, including use of systemic corticosteroids;

4. born at less than 36 weeks gestation;

5. weighing less than 2.5 kg at birth;

6. previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease;

7. known bleeding diathesis, or any condition associated with a prolonged bleeding time;

• who have received any prohibited prior or concomitant medications - e.g.:

1. any immunizations within the 30 days prior to enrollment, with the exception of BCG or hepatitis B;

2. immunoglobulin;

3. any blood products;

• participating in any other clinical trial either currently or in the previous month;
• unable to adhere to the protocol, including plans to move from the area;
• Other:

Had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

• Minimum Eligible Age: 56 Days
• Maximum Eligible Age: 83 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines and Diagnostics

Role: STUDY_CHAIR

Novartis

Locations

Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine

Headington, Oxford, United Kingdom

Countries

United Kingdom

References

Blanchard-Rohner G, Snape MD, Kelly DF, O'Connor D, John T, Clutterbuck EA, Ohene-Kena B, Klinger CL, Odrljin T, Pollard AJ. The B-cell response to a primary and booster course of MenACWY-CRM(1)(9)(7) vaccine administered at 2, 4 and 12 months of age. Vaccine. 2013 May 7;31(20):2441-8. doi: 10.1016/j.vaccine.2013.03.036. Epub 2013 Apr 6.

Reference Type: RESULT

PMID: 23566945 (View on PubMed)

Other Identifiers

2006-003476-35

Identifier Type: -

Identifier Source: secondary_id

V59P16

Identifier Type: -

Identifier Source: org_study_id