Meningococcal Infections, Meningococcal Meningitis
Conditions
Keywords
Immunogenicity, Meningitis, Antibody, Infants
Brief summary
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
Interventions
BIOLOGICALMeningococcal B vaccine
Vaccine candidate formulation I
BIOLOGICALControl
Control
BIOLOGICALMeningococcal B vaccine with antipyretic
Vaccine candidate formulation I with antipyretic
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg * Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements
Exclusion criteria
* Any meningococcal B or C vaccine administration * Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens; * Any ascertained or suspected disease caused by N. meningitidis * Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis * History of severe allergic reaction after previous vaccinations * Recent significant acute or chronic infection * Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw; * Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition) * Any impairment/alteration of the immune system resulting from (for example): * Receipt of any immunosuppressive therapy at any time since birth * Receipt of immunostimulants at any time since birth * Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth * Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation * Participation in another clinical trial * Family members and household members of research staff * History of seizure * Any contraindication to paracetamol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | At baseline (pre-vaccination) and 30 days after the third vaccination. | To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection. |
| Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | Day 1 to day 3 after first vaccination. | To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever \>=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days | To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers. |
| Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | After the third and the booster vaccination. | To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs). |
| Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 12 months (pre-fourth vaccination) | To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication. |
| Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 1 month after fourth vaccination | To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination. |
| Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) | At 13 months | To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age. |
| Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Day 1 through day 7 after each vaccination. | To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination. |
| Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Day 1 through day 7 after second and third vaccination. | To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I). |
| Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Day 1 through day 7 after each vaccination. | To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination. |
| Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Day 1 through day 7 after each vaccination. | To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination. |
| Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Overall study period. | To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period. |
| Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Day 1 through day 7 at 13 months age. | To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants. |
| Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster) | 1 month after booster | To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII). |
| Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age) | ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at: 1. One month after third vaccination. 2. One month after booster vaccination (Men B at 12 months of age). |
Countries
Argentina, Chile, Czechia, Hungary, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| B+OMV (Group I) Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | 188 |
| B+½ OMV (Group II) Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | 190 |
| B+1/4 OMV (Group III) Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | 192 |
| B (Group IV) Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | 188 |
| ½ (B+OMV) (Group V) Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | 191 |
| PH2 B+OMV (Group VI) Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | 188 |
| MenC (Group VII) Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | 186 |
| Par+B+OMV (Group VIII) Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. | 184 |
| Total | 1,507 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Booster Phase | Administrative Reason | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 |
| Booster Phase | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Booster Phase | Lost to Follow-up | 2 | 2 | 4 | 2 | 4 | 4 | 3 | 0 |
| Booster Phase | Protocol Deviation | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Booster Phase | Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
| Overall Study - Prior to Booster Dose | Adverse Event | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 |
| Overall Study - Prior to Booster Dose | Inappropriate enrollment | 0 | 4 | 0 | 0 | 2 | 1 | 1 | 0 |
| Overall Study - Prior to Booster Dose | Lost to Follow-up | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study - Prior to Booster Dose | Protocol Deviation | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study - Prior to Booster Dose | Withdrawal by Subject | 2 | 1 | 3 | 0 | 1 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 188 Participants | 190 Participants | 192 Participants | 188 Participants | 191 Participants | 188 Participants | 186 Participants | 184 Participants | 1507 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 88 Participants | 91 Participants | 82 Participants | 96 Participants | 79 Participants | 93 Participants | 98 Participants | 72 Participants | 699 Participants |
| Sex: Female, Male Male | 100 Participants | 99 Participants | 110 Participants | 92 Participants | 112 Participants | 95 Participants | 88 Participants | 112 Participants | 808 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 181 / 184 | 183 / 184 | 186 / 189 | 183 / 187 | 180 / 187 | 180 / 185 | 175 / 184 | 175 / 183 | 151 / 155 | 159 / 163 | 162 / 169 | 152 / 169 | 154 / 168 | 156 / 165 | 155 / 165 | 150 / 161 |
| serious Total, serious adverse events | 16 / 184 | 20 / 184 | 12 / 189 | 20 / 187 | 13 / 187 | 16 / 185 | 11 / 184 | 15 / 183 | 14 / 155 | 7 / 163 | 12 / 169 | 5 / 169 | 15 / 168 | 9 / 165 | 9 / 165 | 14 / 161 |
Outcome results
Primary
Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever \>=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
Time frame: Day 1 to day 3 after first vaccination.
Population: The analysis was done on the Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B+OMV (Group I) | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | 94 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | 91 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | 74 Subjects |
| B (Group IV) | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | 24 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | 60 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | 76 Subjects |
| MenC (Group VII) | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | 21 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination | 46 Subjects |
Primary
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
Time frame: At baseline (pre-vaccination) and 30 days after the third vaccination.
Population: Analysis as per PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99 > 3rd (N=165,167,161,166,165,161,159,160) | 99 Percentages of Subjects |
| B+OMV (Group I) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76SLBaseline(N=166,171,168,170,169,168,168,166) | 5 Percentages of Subjects |
| B+OMV (Group I) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) | 78 Percentages of Subjects |
| B+OMV (Group I) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254Baseline(N=170,174,171,174,171,173,171,169 | 1 Percentages of Subjects |
| B+OMV (Group I) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99-Baseline (N=162,162,161,161,166,166,161,157) | 5 Percentages of Subjects |
| B+OMV (Group I) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) | 100 Percentages of Subjects |
| B+½ OMV (Group II) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76SLBaseline(N=166,171,168,170,169,168,168,166) | 2 Percentages of Subjects |
| B+½ OMV (Group II) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99-Baseline (N=162,162,161,161,166,166,161,157) | 3 Percentages of Subjects |
| B+½ OMV (Group II) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) | 67 Percentages of Subjects |
| B+½ OMV (Group II) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254Baseline(N=170,174,171,174,171,173,171,169 | 0 Percentages of Subjects |
| B+½ OMV (Group II) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99 > 3rd (N=165,167,161,166,165,161,159,160) | 100 Percentages of Subjects |
| B+½ OMV (Group II) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) | 99 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76SLBaseline(N=166,171,168,170,169,168,168,166) | 4 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99-Baseline (N=162,162,161,161,166,166,161,157) | 6 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) | 99 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99 > 3rd (N=165,167,161,166,165,161,159,160) | 99 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254Baseline(N=170,174,171,174,171,173,171,169 | 1 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) | 56 Percentages of Subjects |
| B (Group IV) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76SLBaseline(N=166,171,168,170,169,168,168,166) | 4 Percentages of Subjects |
| B (Group IV) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99-Baseline (N=162,162,161,161,166,166,161,157) | 4 Percentages of Subjects |
| B (Group IV) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99 > 3rd (N=165,167,161,166,165,161,159,160) | 100 Percentages of Subjects |
| B (Group IV) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) | 1 Percentages of Subjects |
| B (Group IV) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) | 100 Percentages of Subjects |
| B (Group IV) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254Baseline(N=170,174,171,174,171,173,171,169 | 1 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254Baseline(N=170,174,171,174,171,173,171,169 | 1 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) | 99 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76SLBaseline(N=166,171,168,170,169,168,168,166) | 4 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) | 62 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99 > 3rd (N=165,167,161,166,165,161,159,160) | 100 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99-Baseline (N=162,162,161,161,166,166,161,157) | 8 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76SLBaseline(N=166,171,168,170,169,168,168,166) | 4 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254Baseline(N=170,174,171,174,171,173,171,169 | 1 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) | 81 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99-Baseline (N=162,162,161,161,166,166,161,157) | 4 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) | 99 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99 > 3rd (N=165,167,161,166,165,161,159,160) | 99 Percentages of Subjects |
| MenC (Group VII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) | 6 Percentages of Subjects |
| MenC (Group VII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99-Baseline (N=162,162,161,161,166,166,161,157) | 6 Percentages of Subjects |
| MenC (Group VII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) | 2 Percentages of Subjects |
| MenC (Group VII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99 > 3rd (N=165,167,161,166,165,161,159,160) | 3 Percentages of Subjects |
| MenC (Group VII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254Baseline(N=170,174,171,174,171,173,171,169 | 2 Percentages of Subjects |
| MenC (Group VII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76SLBaseline(N=166,171,168,170,169,168,168,166) | 2 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99-Baseline (N=162,162,161,161,166,166,161,157) | 4 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) | 74 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | NZ98/254Baseline(N=170,174,171,174,171,173,171,169 | 1 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 5/99 > 3rd (N=165,167,161,166,165,161,159,160) | 99 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76SLBaseline(N=166,171,168,170,169,168,168,166) | 3 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination | 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) | 100 Percentages of Subjects |
Secondary
Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.
Time frame: At 13 months
Population: The analysis was done on the Per Protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B+OMV (Group I) | Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) | 44/76-SL > Booster (N=65,75) | 120 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) | 5/99 > Booster (N=73,69) | 1950 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) | NZ98/254 > Booster | 20 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) | NZ98/254 > Booster | 2.2 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) | 44/76-SL > Booster (N=65,75) | 12 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) | 5/99 > Booster (N=73,69) | 41 Titers |
Secondary
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at: 1. One month after third vaccination. 2. One month after booster vaccination (Men B at 12 months of age).
Time frame: At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
Population: Per Protocol Primary and Booster populations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254-BaselineN=170,174,171,174,171,173,171,169 | 1.02 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after boosterN=138,152,150,149,152,146,140 | 20 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 | 1.6 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Base Boost(N=71,76,80,72,77,78,70,71) | 69 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3 (N=165,167,161,166,165,161,160) | 396 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Base(N=166,171,168,170,169,168,168,166) | 1.25 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) | 120 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) | 4.94 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3(N=170,170,166,166,169,167,165,167) | 101 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after 3rd vaccN=171,172,169,172,169,169,168 | 10 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99-Baseline-(N=162,162,161,161,166,166,161,157) | 1.18 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Boost(N=73,77,79,72,76,74,69,76) | 1950 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after 3rd vaccN=171,172,169,172,169,169,168 | 7.81 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after boosterN=138,152,150,149,152,146,140 | 18 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Boost(N=73,77,79,72,76,74,69,76) | 1819 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 | 1.28 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254-BaselineN=170,174,171,174,171,173,171,169 | 1.02 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Base Boost(N=71,76,80,72,77,78,70,71) | 91 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3(N=170,170,166,166,169,167,165,167) | 112 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3 (N=165,167,161,166,165,161,160) | 503 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Base(N=166,171,168,170,169,168,168,166) | 1.12 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99-Baseline-(N=162,162,161,161,166,166,161,157) | 1.09 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) | 152 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) | 5.22 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) | 5.72 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Base(N=166,171,168,170,169,168,168,166) | 1.2 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3(N=170,170,166,166,169,167,165,167) | 113 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99-Baseline-(N=162,162,161,161,166,166,161,157) | 1.12 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Base Boost(N=71,76,80,72,77,78,70,71) | 111 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254-BaselineN=170,174,171,174,171,173,171,169 | 1.03 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after 3rd vaccN=171,172,169,172,169,169,168 | 5.74 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 | 1.23 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after boosterN=138,152,150,149,152,146,140 | 11 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) | 118 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3 (N=165,167,161,166,165,161,160) | 534 Titers |
| B+1/4 OMV (Group III) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Boost(N=73,77,79,72,76,74,69,76) | 2238 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after boosterN=138,152,150,149,152,146,140 | 1.67 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3 (N=165,167,161,166,165,161,160) | 389 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) | 5.44 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Base Boost(N=71,76,80,72,77,78,70,71) | 74 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Base(N=166,171,168,170,169,168,168,166) | 1.19 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) | 53 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3(N=170,170,166,166,169,167,165,167) | 62 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after 3rd vaccN=171,172,169,172,169,169,168 | 1.05 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99-Baseline-(N=162,162,161,161,166,166,161,157) | 1.13 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254-BaselineN=170,174,171,174,171,173,171,169 | 1.04 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 | 1.11 Titers |
| B (Group IV) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Boost(N=73,77,79,72,76,74,69,76) | 730 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99-Baseline-(N=162,162,161,161,166,166,161,157) | 1.3 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after boosterN=138,152,150,149,152,146,140 | 14 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3 (N=165,167,161,166,165,161,160) | 316 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Base(N=166,171,168,170,169,168,168,166) | 1.31 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3(N=170,170,166,166,169,167,165,167) | 71 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Base Boost(N=71,76,80,72,77,78,70,71) | 54 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 | 1.35 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) | 3.96 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after 3rd vaccN=171,172,169,172,169,169,168 | 6.66 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254-BaselineN=170,174,171,174,171,173,171,169 | 1.03 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Boost(N=73,77,79,72,76,74,69,76) | 983 Titers |
| ½ (B+OMV) (Group V) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) | 99 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3(N=170,170,166,166,169,167,165,167) | 102 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Boost(N=73,77,79,72,76,74,69,76) | 1321 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after 3rd vaccN=171,172,169,172,169,169,168 | 11 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Base(N=166,171,168,170,169,168,168,166) | 1.2 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 | 1.41 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Base Boost(N=71,76,80,72,77,78,70,71) | 64 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after boosterN=138,152,150,149,152,146,140 | 20 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) | 3.76 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) | 105 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99-Baseline-(N=162,162,161,161,166,166,161,157) | 1.16 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3 (N=165,167,161,166,165,161,160) | 371 Titers |
| PH2 B+OMV (Group VI) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254-BaselineN=170,174,171,174,171,173,171,169 | 1.04 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after 3rd vaccN=171,172,169,172,169,169,168 | 1.05 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Base Boost(N=71,76,80,72,77,78,70,71) | 1.11 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Boost(N=73,77,79,72,76,74,69,76) | 41 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99-Baseline-(N=162,162,161,161,166,166,161,157) | 1.21 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3 (N=165,167,161,166,165,161,160) | 1.15 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254-BaselineN=170,174,171,174,171,173,171,169 | 1.06 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after boosterN=138,152,150,149,152,146,140 | 2.2 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 | 1.03 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Base(N=166,171,168,170,169,168,168,166) | 1.16 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3(N=170,170,166,166,169,167,165,167) | 1.24 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) | 12 Titers |
| MenC (Group VII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) | 1.15 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 | 1.48 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after boosterN=138,152,150,149,152,146,140 | 20 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) | 136 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 1month after 3rd vaccN=171,172,169,172,169,169,168 | 8.48 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99-Baseline-(N=162,162,161,161,166,166,161,157) | 1.07 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Base(N=166,171,168,170,169,168,168,166) | 1.18 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254-BaselineN=170,174,171,174,171,173,171,169 | 1.02 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Boost(N=73,77,79,72,76,74,69,76) | 2182 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Base Boost(N=71,76,80,72,77,78,70,71) | 106 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3 (N=165,167,161,166,165,161,160) | 455 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3(N=170,170,166,166,169,167,165,167) | 102 Titers |
| Par+B+OMV (Group VIII) | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) | 4.51 Titers |
Secondary
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.
Time frame: At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
Population: As per PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Strain - Baseline (N=166,166) | 1.25 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3rd (N=170,167) | 101 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 > booster (N= 138, 140) | 20 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Baseline booster (N=69,70) | 4.94 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > booster (N=65,63) | 120 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Strain - Baseline (N=162,157) | 1.18 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3rd (N=165,160) | 396 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Baseline booster (N=71,71) | 69 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > booser (N=73,76) | 1950 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Strain-Baseline (N=170,169) | 1.02 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 > 3rd (N=171,168) | 10 Titers |
| B+OMV (Group I) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Baseline booster (N=141,143) | 1.6 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Baseline booster (N=141,143) | 1.48 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > booser (N=73,76) | 2182 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3rd (N=170,167) | 102 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Strain - Baseline (N=162,157) | 1.07 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 Strain-Baseline (N=170,169) | 1.02 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3rd (N=165,160) | 455 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 > booster (N= 138, 140) | 20 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Strain - Baseline (N=166,166) | 1.18 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 > 3rd (N=171,168) | 8.48 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL Baseline booster (N=69,70) | 4.51 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 Baseline booster (N=71,71) | 106 Titers |
| B+½ OMV (Group II) | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > booster (N=65,63) | 136 Titers |
Secondary
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).
Time frame: After the third and the booster vaccination.
Population: As per PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| B+OMV (Group I) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3rd (N=152,142) | 345 Ratios |
| B+OMV (Group I) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Booster (N=68,68) | 27 Ratios |
| B+OMV (Group I) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 > 3rd (N=162,160) | 9.65 Ratios |
| B+OMV (Group I) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3rd (N=157,157) | 80 Ratios |
| B+OMV (Group I) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Booster (N=59,56) | 24 Ratios |
| B+OMV (Group I) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 > Booster (N=129,127) | 12 Ratios |
| B+½ OMV (Group II) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > Booster (N=59,56) | 28 Ratios |
| B+½ OMV (Group II) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > 3rd (N=152,142) | 417 Ratios |
| B+½ OMV (Group II) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 44/76-SL > 3rd (N=157,157) | 84 Ratios |
| B+½ OMV (Group II) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | 5/99 > Booster (N=68,68) | 20 Ratios |
| B+½ OMV (Group II) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 > Booster (N=129,127) | 14 Ratios |
| B+½ OMV (Group II) | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) | NZ98/254 > 3rd (N=162,160) | 8.69 Ratios |
Secondary
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.
Time frame: Day 1 through day 7 at 13 months age.
Population: The analysis was performed on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Injection Site Tenderness | 92 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Injection Site Erythema | 84 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Injection Site Induration | 59 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Injection Site Swelling | 35 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Change Eat. Habits (N=155) | 43 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Sleepiness | 57 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Vomiting | 8 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Diarrhea | 18 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Irritability | 75 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Unus Crying | 37 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Rash | 4 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Fever ( ≥ 38.5°C ) (N=158) | 35 Subjects |
| B+OMV (Group I) | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group | Antipyr. Med. Used (N=157) | 47 Subjects |
Secondary
Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.
Time frame: Overall study period.
Population: The analysis was performed on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Tr E SAE Boost (N=155,163,169,169,168,165,165,161) | 14 Subjects |
| B+OMV (Group I) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Treatment Emergent SAEs - Primary Vacc | 16 Subjects |
| B+OMV (Group I) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | AE Leading to Premature Withdrawal-Primary Vacc | 0 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | AE Leading to Premature Withdrawal-Primary Vacc | 2 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Tr E SAE Boost (N=155,163,169,169,168,165,165,161) | 7 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Treatment Emergent SAEs - Primary Vacc | 20 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | AE Leading to Premature Withdrawal-Primary Vacc | 2 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Treatment Emergent SAEs - Primary Vacc | 12 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Tr E SAE Boost (N=155,163,169,169,168,165,165,161) | 12 Subjects |
| B (Group IV) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Tr E SAE Boost (N=155,163,169,169,168,165,165,161) | 5 Subjects |
| B (Group IV) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Treatment Emergent SAEs - Primary Vacc | 20 Subjects |
| B (Group IV) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | AE Leading to Premature Withdrawal-Primary Vacc | 0 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | AE Leading to Premature Withdrawal-Primary Vacc | 0 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Tr E SAE Boost (N=155,163,169,169,168,165,165,161) | 15 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Treatment Emergent SAEs - Primary Vacc | 13 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Tr E SAE Boost (N=155,163,169,169,168,165,165,161) | 9 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | AE Leading to Premature Withdrawal-Primary Vacc | 1 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Treatment Emergent SAEs - Primary Vacc | 16 Subjects |
| MenC (Group VII) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Treatment Emergent SAEs - Primary Vacc | 11 Subjects |
| MenC (Group VII) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | AE Leading to Premature Withdrawal-Primary Vacc | 2 Subjects |
| MenC (Group VII) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Tr E SAE Boost (N=155,163,169,169,168,165,165,161) | 9 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Treatment Emergent SAEs - Primary Vacc | 15 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | AE Leading to Premature Withdrawal-Primary Vacc | 1 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. | Tr E SAE Boost (N=155,163,169,169,168,165,165,161) | 16 Subjects |
Secondary
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.
Time frame: Day 1 through day 7 after each vaccination.
Population: The analysis was performed on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Third Vacc) | 97 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Second Vacc) | 103 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Third Vacc) | 102 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Second Vacc) | 64 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (First Vacc) | 108 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Booster Vacc) | 73 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (First Vacc) | 114 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Booster Vacc) | 55 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (First Vacc) | 163 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (Second Vacc) | 156 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (First Vacc) | 101 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Booster Vacc) | 90 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Third Vacc) | 110 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Second Vacc) | 104 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local BoostN=155,162,169,168,168,165,162,159 | 131 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Third Vacc) | 56 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (3rd N=181,179,185,183,181,180,177,179) | 151 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Second Vacc) | 121 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Booster Vacc) | 116 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (First Vacc) | 58 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Booster Vacc) | 101 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Second Vacc) | 114 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Booster Vacc) | 59 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Second Vacc) | 61 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (Second Vacc) | 156 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Second Vacc) | 105 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (First Vacc) | 49 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Second Vacc) | 116 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (First Vacc) | 116 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (First Vacc) | 99 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (First Vacc) | 155 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Booster Vacc) | 83 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Third Vacc) | 98 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (First Vacc) | 98 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local BoostN=155,162,169,168,168,165,162,159 | 132 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Third Vacc) | 92 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Third Vacc) | 56 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Third Vacc) | 106 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (3rd N=181,179,185,183,181,180,177,179) | 147 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Booster Vacc) | 107 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Second Vacc) | 114 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local BoostN=155,162,169,168,168,165,162,159 | 149 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (3rd N=181,179,185,183,181,180,177,179) | 141 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (First Vacc) | 94 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Booster Vacc) | 69 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Third Vacc) | 92 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (First Vacc) | 85 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (First Vacc) | 55 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Third Vacc) | 112 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Second Vacc) | 54 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Third Vacc) | 46 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (First Vacc) | 153 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Booster Vacc) | 95 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Second Vacc) | 97 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (First Vacc) | 111 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Second Vacc) | 97 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Booster Vacc) | 116 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Third Vacc) | 78 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (Second Vacc) | 155 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Booster Vacc) | 120 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (First Vacc) | 123 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (Second Vacc) | 126 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Second Vacc) | 63 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Second Vacc) | 34 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (3rd N=181,179,185,183,181,180,177,179) | 122 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Third Vacc) | 47 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Third Vacc) | 72 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Third Vacc) | 62 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Booster Vacc) | 67 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Booster Vacc) | 31 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Third Vacc) | 35 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local BoostN=155,162,169,168,168,165,162,159 | 113 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Booster Vacc) | 77 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Booster Vacc) | 56 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (First Vacc) | 54 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (First Vacc) | 53 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (First Vacc) | 48 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (First Vacc) | 24 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Second Vacc) | 48 Subjects |
| B (Group IV) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Second Vacc) | 71 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (First Vacc) | 97 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Booster Vacc) | 80 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Second Vacc) | 88 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Second Vacc) | 50 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (3rd N=181,179,185,183,181,180,177,179) | 130 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Booster Vacc) | 66 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Third Vacc) | 79 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (First Vacc) | 141 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Third Vacc) | 45 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local BoostN=155,162,169,168,168,165,162,159 | 127 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (Second Vacc) | 132 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (First Vacc) | 48 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (First Vacc) | 86 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Third Vacc) | 94 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Second Vacc) | 90 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Third Vacc) | 77 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (First Vacc) | 77 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Booster Vacc) | 106 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Booster Vacc) | 47 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Second Vacc) | 83 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local BoostN=155,162,169,168,168,165,162,159 | 130 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Third Vacc) | 89 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Third Vacc) | 101 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Third Vacc) | 58 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Booster Vacc) | 112 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Booster Vacc) | 85 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (3rd N=181,179,185,183,181,180,177,179) | 152 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Booster Vacc) | 73 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Second Vacc) | 58 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (First Vacc) | 157 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (First Vacc) | 121 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Second Vacc) | 94 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Second Vacc) | 104 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (First Vacc) | 106 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (First Vacc) | 84 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (Second Vacc) | 156 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (First Vacc) | 60 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Second Vacc) | 116 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Booster Vacc) | 52 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Third Vacc) | 111 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Third Vacc) | 55 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local BoostN=155,162,169,168,168,165,162,159 | 133 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (First Vacc) | 45 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Second Vacc) | 21 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Third Vacc) | 63 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (Second Vacc) | 118 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (3rd N=181,179,185,183,181,180,177,179) | 113 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Third Vacc) | 29 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (First Vacc) | 15 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (First Vacc) | 48 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Second Vacc) | 47 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Booster Vacc) | 62 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Second Vacc) | 44 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Booster Vacc) | 39 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Booster Vacc) | 108 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Second Vacc) | 38 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (First Vacc) | 25 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Booster Vacc) | 93 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Third Vacc) | 42 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (First Vacc) | 127 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (Second Vacc) | 140 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Second Vacc) | 79 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (First Vacc) | 82 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Booster Vacc) | 92 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Third Vacc) | 66 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (First Vacc) | 79 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Second Vacc) | 52 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (First Vacc) | 41 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (First Vacc) | 73 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Tenderness (Second Vacc) | 85 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Third Vacc) | 91 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local BoostN=155,162,169,168,168,165,162,159 | 121 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (First Vacc) | 137 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Second Vacc) | 94 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Third Vacc) | 47 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Local (3rd N=181,179,185,183,181,180,177,179) | 128 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Booster Vacc) | 60 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Swelling (Booster Vacc) | 47 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Erythema (Booster Vacc) | 81 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination | Injection Site Induration (Third Vacc) | 80 Subjects |
Secondary
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.
Time frame: Day 1 through day 7 after each vaccination.
Population: The analysis was performed on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Booster Vacc) | 6 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Third Vacc) | 75 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst (3rdN=181,179,185,182,181,180,177,179) | 146 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Third Vacc) | 49 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Booster Vacc) | 30 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (First Vacc) | 102 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Booster Vacc) | 74 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Third Vacc) | 1 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Third Vacc) | 8 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Second Vacc) | 90 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Second Vacc) | 105 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Third Vacc) | 33 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Second Vacc) | 130 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Second Vacc) | 43 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Booster Vacc) | 81 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Booster Vacc) | 116 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Second Vacc) | 100 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (First Vacc) | 128 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Second Vacc) | 18 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Booster Vacc) | 5 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (First Vacc) | 76 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (First Vacc) | 95 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Booster Vacc) | 84 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (First Vacc) | 57 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Second Vacc) | 62 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (Second Vacc) | 168 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Third Vacc) | 76 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Third Vacc) | 66 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Third Vacc) | 115 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Second Vacc) | 4 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (First Vacc) | 94 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Booster Vacc) | 74 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (First Vacc) | 6 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Booster Vacc) | 76 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst(BoosterN=155,162,169,169,168,165,164,159) | 143 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Third Vacc) | 55 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Second Vacc) | 90 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (First Vacc) | 24 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (First Vacc) | 167 Subjects |
| B+OMV (Group I) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (First Vacc) | 120 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Booster Vacc) | 90 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (Second Vacc) | 158 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Second Vacc) | 55 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Third Vacc) | 6 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Second Vacc) | 100 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Booster Vacc) | 5 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Third Vacc) | 82 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Third Vacc) | 29 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Third Vacc) | 97 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Second Vacc) | 9 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (First Vacc) | 5 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Second Vacc) | 82 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Booster Vacc) | 64 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst (3rdN=181,179,185,182,181,180,177,179) | 131 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Booster Vacc) | 111 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Second Vacc) | 18 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Second Vacc) | 41 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Second Vacc) | 94 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Second Vacc) | 121 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Third Vacc) | 18 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Second Vacc) | 90 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Booster Vacc) | 34 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Third Vacc) | 67 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Third Vacc) | 50 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Booster Vacc) | 11 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (First Vacc) | 87 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (First Vacc) | 173 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Booster Vacc) | 82 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Booster Vacc) | 77 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (First Vacc) | 131 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (First Vacc) | 55 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (First Vacc) | 101 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Booster Vacc) | 86 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst(BoosterN=155,162,169,169,168,165,164,159) | 144 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Third Vacc) | 60 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (First Vacc) | 91 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (First Vacc) | 94 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (First Vacc) | 124 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (First Vacc) | 18 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Third Vacc) | 53 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Third Vacc) | 39 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (First Vacc) | 54 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (First Vacc) | 74 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Third Vacc) | 4 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Booster Vacc) | 90 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (First Vacc) | 175 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Second Vacc) | 77 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Third Vacc) | 38 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Booster Vacc) | 8 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (First Vacc) | 5 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Booster Vacc) | 64 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Third Vacc) | 82 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Booster Vacc) | 79 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (First Vacc) | 128 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (First Vacc) | 84 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Second Vacc) | 4 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Third Vacc) | 62 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (First Vacc) | 119 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Second Vacc) | 47 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (First Vacc) | 92 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Second Vacc) | 14 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Second Vacc) | 58 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Second Vacc) | 124 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (First Vacc) | 105 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Booster Vacc) | 36 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Booster Vacc) | 112 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (First Vacc) | 25 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Second Vacc) | 84 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst (3rdN=181,179,185,182,181,180,177,179) | 132 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Second Vacc) | 83 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Third Vacc) | 93 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Booster Vacc) | 69 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (Second Vacc) | 166 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Booster Vacc) | 7 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Third Vacc) | 42 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Third Vacc) | 15 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Second Vacc) | 102 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst(BoosterN=155,162,169,169,168,165,164,159) | 139 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Booster Vacc) | 83 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Third Vacc) | 51 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Second Vacc) | 36 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Second Vacc) | 40 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Third Vacc) | 12 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst (3rdN=181,179,185,182,181,180,177,179) | 122 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (First Vacc) | 31 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Third Vacc) | 64 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Third Vacc) | 37 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Booster Vacc) | 2 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (First Vacc) | 99 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Booster Vacc) | 46 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (First Vacc) | 24 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (First Vacc) | 52 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (First Vacc) | 152 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Booster Vacc) | 86 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Second Vacc) | 40 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Booster Vacc) | 43 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Second Vacc) | 94 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Second Vacc) | 70 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (First Vacc) | 96 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Booster Vacc) | 7 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Booster Vacc) | 42 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Third Vacc) | 26 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Booster Vacc) | 63 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Booster Vacc) | 52 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (First Vacc) | 61 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst(BoosterN=155,162,169,169,168,165,164,159) | 118 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (First Vacc) | 7 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Third Vacc) | 16 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (First Vacc) | 37 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Third Vacc) | 2 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (Second Vacc) | 144 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Second Vacc) | 53 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (First Vacc) | 15 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Second Vacc) | 85 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Second Vacc) | 15 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Third Vacc) | 47 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Booster Vacc) | 43 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Second Vacc) | 5 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Third Vacc) | 31 Subjects |
| B (Group IV) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Third Vacc) | 74 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Second Vacc) | 74 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (First Vacc) | 84 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (First Vacc) | 117 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (First Vacc) | 22 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (First Vacc) | 41 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (First Vacc) | 131 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (First Vacc) | 60 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Second Vacc) | 92 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Second Vacc) | 39 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Second Vacc) | 83 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Third Vacc) | 12 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Third Vacc) | 34 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (First Vacc) | 162 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (First Vacc) | 96 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (First Vacc) | 10 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (First Vacc) | 74 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (Second Vacc) | 156 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Second Vacc) | 60 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Second Vacc) | 17 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Second Vacc) | 117 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Second Vacc) | 7 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Second Vacc) | 79 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst (3rdN=181,179,185,182,181,180,177,179) | 141 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Third Vacc) | 45 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Third Vacc) | 77 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Third Vacc) | 104 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Third Vacc) | 69 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Third Vacc) | 8 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Third Vacc) | 42 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Third Vacc) | 49 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst(BoosterN=155,162,169,169,168,165,164,159) | 141 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Booster Vacc) | 70 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Booster Vacc) | 86 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Booster Vacc) | 10 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Booster Vacc) | 32 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Booster Vacc) | 116 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Booster Vacc) | 71 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Booster Vacc) | 8 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Booster Vacc) | 78 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Booster Vacc) | 75 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Booster Vacc) | 68 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Second Vacc) | 47 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Third Vacc) | 60 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (First Vacc) | 10 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Second Vacc) | 4 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (First Vacc) | 108 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Second Vacc) | 20 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst(BoosterN=155,162,169,169,168,165,164,159) | 142 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Third Vacc) | 40 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Booster Vacc) | 30 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (First Vacc) | 119 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Second Vacc) | 99 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Third Vacc) | 100 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (First Vacc) | 90 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Booster Vacc) | 9 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Booster Vacc) | 80 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Second Vacc) | 105 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Second Vacc) | 90 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (First Vacc) | 49 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (First Vacc) | 171 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Third Vacc) | 63 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Booster Vacc) | 4 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Booster Vacc) | 88 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Booster Vacc) | 80 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Third Vacc) | 13 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Second Vacc) | 80 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (First Vacc) | 131 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (First Vacc) | 26 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Third Vacc) | 10 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst (3rdN=181,179,185,182,181,180,177,179) | 151 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Booster Vacc) | 82 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Third Vacc) | 115 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (First Vacc) | 95 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (Second Vacc) | 158 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Second Vacc) | 126 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Third Vacc) | 79 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Third Vacc) | 54 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Booster Vacc) | 115 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (First Vacc) | 76 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Second Vacc) | 109 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Third Vacc) | 22 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Second Vacc) | 30 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Second Vacc) | 5 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Third Vacc) | 76 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Third Vacc) | 19 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Second Vacc) | 82 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Second Vacc) | 14 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (First Vacc) | 17 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Third Vacc) | 38 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Third Vacc) | 14 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Second Vacc) | 33 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Third Vacc) | 6 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (First Vacc) | 32 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (First Vacc) | 22 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Booster Vacc) | 92 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (First Vacc) | 4 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (First Vacc) | 63 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Booster Vacc) | 84 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst(BoosterN=155,162,169,169,168,165,164,159) | 142 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (First Vacc) | 41 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Booster Vacc) | 59 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (First Vacc) | 136 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Booster Vacc) | 9 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Booster Vacc) | 85 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Third Vacc) | 20 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (First Vacc) | 92 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Second Vacc) | 45 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Second Vacc) | 39 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Booster Vacc) | 26 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Second Vacc) | 75 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Booster Vacc) | 117 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (Second Vacc) | 126 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Booster Vacc) | 73 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (First Vacc) | 79 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Booster Vacc) | 6 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (First Vacc) | 45 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Third Vacc) | 52 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst (3rdN=181,179,185,182,181,180,177,179) | 106 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Second Vacc) | 39 Subjects |
| MenC (Group VII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Third Vacc) | 11 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Third Vacc) | 153 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Second Vacc) | 84 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Second Vacc) | 40 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (First Vacc) | 5 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (First Vacc) | 150 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Third Vacc) | 20 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Third Vacc) | 32 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Booster Vacc) | 96 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Systemic (Second Vacc) | 147 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Third Vacc) | 75 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (First Vacc) | 46 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (First Vacc) | 74 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Booster Vacc) | 128 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Third Vacc) | 6 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Third Vacc) | 84 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Booster Vacc) | 50 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (First Vacc) | 97 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Second Vacc) | 71 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (First Vacc) | 166 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (First Vacc) | 41 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Second Vacc) | 54 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Unus Crying (Third Vacc) | 47 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Antipyr. Med. Used (Second Vacc) | 163 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (First Vacc) | 116 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Booster Vacc) | 5 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Sleepiness (Booster Vacc) | 80 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Second Vacc) | 35 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Booster Vacc) | 20 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Booster Vacc) | 66 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Rash (Second Vacc) | 5 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (Third Vacc) | 48 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Fever ( ≥ 38.5°C ) (Booster Vacc) | 58 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Second Vacc) | 20 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Change Eat. Habits (First Vacc) | 66 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Irritability (Second Vacc) | 99 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst (3rdN=181,179,185,182,181,180,177,179) | 127 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (First Vacc) | 22 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Any Syst(BoosterN=155,162,169,169,168,165,164,159) | 137 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Vomiting (Third Vacc) | 20 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination | Diarrhea (Booster Vacc) | 30 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.
Time frame: Day 1 through day 7 after each vaccination.
Population: The analysis was performed on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Booster Vacc) | 28 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Second Vaccination) | 49 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 | 55 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (First Vacc) | 0 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Third Vacc) | 34 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 | 40 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 | 35 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Second Vacc) | 1 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (First Vacc) | 48 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE (Day 1 to 7) (First Vacc) | 55 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Third Vacc) | 2 Subjects |
| B+OMV (Group I) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Booster Vacc) | 0 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Booster Vacc) | 41 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Second Vaccination) | 45 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Third Vacc) | 0 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Booster Vacc) | 1 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE (Day 1 to 7) (First Vacc) | 52 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Second Vacc) | 0 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (First Vacc) | 48 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Third Vacc) | 52 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (First Vacc) | 1 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 | 46 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 | 53 Subjects |
| B+½ OMV (Group II) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 | 59 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Booster Vacc) | 48 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 | 50 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Second Vacc) | 1 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE (Day 1 to 7) (First Vacc) | 51 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Third Vacc) | 45 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (First Vacc) | 43 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 | 56 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (First Vacc) | 0 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 | 49 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Third Vacc) | 2 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Booster Vacc) | 2 Subjects |
| B+1/4 OMV (Group III) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Second Vaccination) | 45 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Second Vacc) | 0 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (First Vacc) | 30 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 | 35 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 | 35 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Third Vacc) | 0 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (First Vacc) | 0 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Second Vaccination) | 36 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Booster Vacc) | 0 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Booster Vacc) | 23 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE (Day 1 to 7) (First Vacc) | 33 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Third Vacc) | 29 Subjects |
| B (Group IV) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 | 41 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Booster Vacc) | 23 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Booster Vacc) | 3 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Third Vacc) | 23 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (First Vacc) | 27 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Second Vacc) | 1 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 | 36 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE (Day 1 to 7) (First Vacc) | 35 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Second Vaccination) | 33 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 | 31 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 | 29 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Third Vacc) | 1 Subjects |
| ½ (B+OMV) (Group V) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (First Vacc) | 0 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Third Vacc) | 0 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 | 30 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Booster Vacc) | 26 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Booster Vacc) | 0 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE (Day 1 to 7) (First Vacc) | 39 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (First Vacc) | 34 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (First Vacc) | 1 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 | 47 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Second Vaccination) | 41 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Second Vacc) | 0 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 | 45 Subjects |
| PH2 B+OMV (Group VI) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Third Vacc) | 37 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Second Vacc) | 0 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Second Vaccination) | 26 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 | 28 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (First Vacc) | 0 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 | 35 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (First Vacc) | 22 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE (Day 1 to 7) (First Vacc) | 27 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Third Vacc) | 0 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Third Vacc) | 29 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Booster Vacc) | 0 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Booster Vacc) | 30 Subjects |
| MenC (Group VII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 | 37 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE (Day 1 to 7) (First Vacc) | 42 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Second Vacc) | 0 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Second Vaccination) | 39 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 | 45 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Booster Vacc) | 0 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (First Vacc) | 1 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Booster Vacc) | 25 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any SAE (Third Vacc) | 0 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 | 30 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 | 39 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (First Vacc) | 36 Subjects |
| Par+B+OMV (Group VIII) | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination | At least Possibly related AE (Third Vacc) | 36 Subjects |
Secondary
Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).
Time frame: 1 month after booster
Population: The analysis was done on the Per Protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster) | 44/76-SL > Booster (N=75) | 84 Percentage of Subjects |
| B+OMV (Group I) | Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster) | 5/99 > Booster (N=69) | 93 Percentage of Subjects |
| B+OMV (Group I) | Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster) | NZ98/254 > Booster | 24 Percentage of Subjects |
Secondary
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.
Time frame: 1 month after fourth vaccination
Population: The analysis was done on the Per Protocol Booster population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 5/99 strain (N=73,77,79,72,76,74,76) | 100 Percentages of Subjects |
| B+OMV (Group I) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | NZ98/254 (N=138,152,150,149,152,146,147,140) | 89 Percentages of Subjects |
| B+OMV (Group I) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 44/76-SL > Booster(N=65,73,70,75,76,71,63) | 100 Percentages of Subjects |
| B+½ OMV (Group II) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | NZ98/254 (N=138,152,150,149,152,146,147,140) | 89 Percentages of Subjects |
| B+½ OMV (Group II) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 5/99 strain (N=73,77,79,72,76,74,76) | 100 Percentages of Subjects |
| B+½ OMV (Group II) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 44/76-SL > Booster(N=65,73,70,75,76,71,63) | 100 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 5/99 strain (N=73,77,79,72,76,74,76) | 100 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 44/76-SL > Booster(N=65,73,70,75,76,71,63) | 100 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | NZ98/254 (N=138,152,150,149,152,146,147,140) | 78 Percentages of Subjects |
| B (Group IV) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 44/76-SL > Booster(N=65,73,70,75,76,71,63) | 97 Percentages of Subjects |
| B (Group IV) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | NZ98/254 (N=138,152,150,149,152,146,147,140) | 18 Percentages of Subjects |
| B (Group IV) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 5/99 strain (N=73,77,79,72,76,74,76) | 100 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 5/99 strain (N=73,77,79,72,76,74,76) | 100 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 44/76-SL > Booster(N=65,73,70,75,76,71,63) | 100 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | NZ98/254 (N=138,152,150,149,152,146,147,140) | 83 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 44/76-SL > Booster(N=65,73,70,75,76,71,63) | 99 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 5/99 strain (N=73,77,79,72,76,74,76) | 100 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | NZ98/254 (N=138,152,150,149,152,146,147,140) | 88 Percentages of Subjects |
| MenC (Group VII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 5/99 strain (N=73,77,79,72,76,74,76) | 93 Percentages of Subjects |
| MenC (Group VII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | NZ98/254 (N=138,152,150,149,152,146,147,140) | 24 Percentages of Subjects |
| MenC (Group VII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 44/76-SL > Booster(N=65,73,70,75,76,71,63) | 84 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | NZ98/254 (N=138,152,150,149,152,146,147,140) | 90 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 44/76-SL > Booster(N=65,73,70,75,76,71,63) | 100 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) | 5/99 strain (N=73,77,79,72,76,74,76) | 100 Percentages of Subjects |
Secondary
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.
Time frame: 12 months (pre-fourth vaccination)
Population: The analysis was done on the Per Protocol Booster population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) | 55 Percentages of Subjects |
| B+OMV (Group I) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) | 97 Percentages of Subjects |
| B+OMV (Group I) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) | 12 Percentages of Subjects |
| B+½ OMV (Group II) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) | 100 Percentages of Subjects |
| B+½ OMV (Group II) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) | 58 Percentages of Subjects |
| B+½ OMV (Group II) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) | 6 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) | 100 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) | 5 Percentages of Subjects |
| B+1/4 OMV (Group III) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) | 66 Percentages of Subjects |
| B (Group IV) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) | 3 Percentages of Subjects |
| B (Group IV) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) | 97 Percentages of Subjects |
| B (Group IV) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) | 63 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) | 7 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) | 45 Percentages of Subjects |
| ½ (B+OMV) (Group V) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) | 97 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) | 8 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) | 99 Percentages of Subjects |
| PH2 B+OMV (Group VI) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) | 44 Percentages of Subjects |
| MenC (Group VII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) | 1 Percentages of Subjects |
| MenC (Group VII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) | 4 Percentages of Subjects |
| MenC (Group VII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) | 0 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) | 47 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) | 11 Percentages of Subjects |
| Par+B+OMV (Group VIII) | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) | 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) | 100 Percentages of Subjects |
Secondary
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).
Time frame: Day 1 through day 7 after second and third vaccination.
Population: As per safety dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B+OMV (Group I) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Booster d 1-7(N=155,162,169,168,168,165,164,159) | 81 Subjects |
| B+OMV (Group I) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | First Vaccination (day1-7) | 94 Subjects |
| B+OMV (Group I) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day1-3) | 90 Subjects |
| B+OMV (Group I) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) | 55 Subjects |
| B+OMV (Group I) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day 1-7) | 90 Subjects |
| B+OMV (Group I) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) | 55 Subjects |
| B+½ OMV (Group II) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Booster d 1-7(N=155,162,169,168,168,165,164,159) | 86 Subjects |
| B+½ OMV (Group II) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day1-3) | 82 Subjects |
| B+½ OMV (Group II) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | First Vaccination (day1-7) | 91 Subjects |
| B+½ OMV (Group II) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) | 50 Subjects |
| B+½ OMV (Group II) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) | 53 Subjects |
| B+½ OMV (Group II) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day 1-7) | 82 Subjects |
| B+1/4 OMV (Group III) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) | 36 Subjects |
| B+1/4 OMV (Group III) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) | 38 Subjects |
| B+1/4 OMV (Group III) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Booster d 1-7(N=155,162,169,168,168,165,164,159) | 64 Subjects |
| B+1/4 OMV (Group III) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day1-3) | 76 Subjects |
| B+1/4 OMV (Group III) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | First Vaccination (day1-7) | 74 Subjects |
| B+1/4 OMV (Group III) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day 1-7) | 77 Subjects |
| B (Group IV) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day1-3) | 35 Subjects |
| B (Group IV) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) | 15 Subjects |
| B (Group IV) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | First Vaccination (day1-7) | 24 Subjects |
| B (Group IV) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day 1-7) | 36 Subjects |
| B (Group IV) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Booster d 1-7(N=155,162,169,168,168,165,164,159) | 43 Subjects |
| B (Group IV) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) | 16 Subjects |
| ½ (B+OMV) (Group V) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day 1-7) | 74 Subjects |
| ½ (B+OMV) (Group V) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) | 42 Subjects |
| ½ (B+OMV) (Group V) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day1-3) | 74 Subjects |
| ½ (B+OMV) (Group V) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | First Vaccination (day1-7) | 60 Subjects |
| ½ (B+OMV) (Group V) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) | 40 Subjects |
| ½ (B+OMV) (Group V) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Booster d 1-7(N=155,162,169,168,168,165,164,159) | 78 Subjects |
| PH2 B+OMV (Group VI) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Booster d 1-7(N=155,162,169,168,168,165,164,159) | 68 Subjects |
| PH2 B+OMV (Group VI) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) | 54 Subjects |
| PH2 B+OMV (Group VI) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day 1-7) | 90 Subjects |
| PH2 B+OMV (Group VI) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day1-3) | 89 Subjects |
| PH2 B+OMV (Group VI) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | First Vaccination (day1-7) | 76 Subjects |
| PH2 B+OMV (Group VI) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) | 53 Subjects |
| MenC (Group VII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day1-3) | 30 Subjects |
| MenC (Group VII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Booster d 1-7(N=155,162,169,168,168,165,164,159) | 84 Subjects |
| MenC (Group VII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | First Vaccination (day1-7) | 22 Subjects |
| MenC (Group VII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day 1-7) | 30 Subjects |
| MenC (Group VII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) | 14 Subjects |
| MenC (Group VII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) | 12 Subjects |
| Par+B+OMV (Group VIII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) | 20 Subjects |
| Par+B+OMV (Group VIII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Booster d 1-7(N=155,162,169,168,168,165,164,159) | 58 Subjects |
| Par+B+OMV (Group VIII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day 1-7) | 35 Subjects |
| Par+B+OMV (Group VIII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | First Vaccination (day1-7) | 46 Subjects |
| Par+B+OMV (Group VIII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | Second Vaccination (day1-3) | 33 Subjects |
| Par+B+OMV (Group VIII) | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination | 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) | 20 Subjects |