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Research Paper

A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration

Pages 786-799 | Received 30 Apr 2018, Accepted 24 Nov 2018, Published online: 20 Feb 2019

Figures & data

Figure 1. Focus on the patient section.

Figure 1. Focus on the patient section.

Figure 2. Flow diagram of the study participants in each sub-cohort.

Footnote: ATP, according-to-protocol; DTaP-IPV, diphtheria, tetanus, acellular pertussis, and inactivated polio vaccine; N, number of participants; n, number of participants within the category; VV, varicella vaccine.
Figure 2. Flow diagram of the study participants in each sub-cohort.

Table 1. Demographic characteristics of the study participants (total vaccinated cohort).

Table 2. Anti-measles, anti-mumps, and anti-rubella seroresponse rates and geometric mean antibody concentrations at Day 42 when MMR-RIT and MMR II were co-administered with DTaP-IPV and VV (according-to-protocol cohort for immunogenicity, sub-cohort 1).

Table 3. Anti-measles, anti-mumps, and anti-rubella seroresponse rates and geometric mean antibody concentrations at Day 42 when MMR-RIT and MMR II were administered alone (according-to-protocol cohort for immunogenicity, sub-cohort 2).

Table 4. Seroresponse rate and booster response rate to antibodies to the co-administered vaccines at Day 42 (according-to-protocol cohort for immunogenicity, sub-cohort 1).

Table 5. Geometric mean antibody concentrations or titers to the co-administered vaccines at Day 42 (according-to-protocol cohort for immunogenicity, sub-cohort 1).

Figure 3. Incidence, in each sub-cohort, of solicited injection site adverse events (Day 0–3), fever (Day 0–42), and drowsiness and loss of appetite (Day 0–3; only assessed in sub-cohort 1) (total vaccinated cohort).

Footnote: N, number of participants with at least 1 vaccine administration documented.*Except for fever, drowsiness, and loss of appetite in sub-cohort 1 (MMR-RIT, N = 731 and MMR II, N = 268); fever in sub-cohort 2 (MMR-RIT, N = 767 and MMR II, N = 291); and fever in sub-cohort 3 (MMR-RIT, N = 1291 and MMR II, N = 481). Children in sub-cohort 1 received either MMR-RIT or MMR II together with DTaP-IPV and VV; children in sub-cohorts 2 and 3 received either MMR-RIT or MMR II alone.The injection site adverse events (i.e., pain, redness, and swelling) refer to the site of MMR vaccine injection. Fever: temperature ≥38.0°C. Grade 3 was defined as: limb spontaneously painful or child cried when limb was moved (pain); diameter >50 mm (redness, swelling); temperature >39.5°C (fever); adverse event preventing normal, everyday activities (drowsiness); not eating at all (loss of appetite). The error bars represent the upper and lower limits of the exact two-sided 95% confidence intervals.
Figure 3. Incidence, in each sub-cohort, of solicited injection site adverse events (Day 0–3), fever (Day 0–42), and drowsiness and loss of appetite (Day 0–3; only assessed in sub-cohort 1) (total vaccinated cohort).

Table 6. Incidence of rash, parotid/salivary gland swelling, and febrile convulsions/headaches (Day 0–42) (total vaccinated cohort).

Table 7. Incidence of reported unsolicited adverse events (Day 0–42), serious adverse events, and NOCDs (Day 0–180) (total vaccinated cohort).

Figure 4. Study design.

Footnote:
, blood sampling;
, vaccine administration (includes administration of DTaP-IPV and VV in sub-cohort 1); AEs, adverse events; DTaP-IPV, diphtheria, tetanus, acellular pertussis, and inactivated polio vaccine; NOCDs, new onset chronic diseases; SAEs, serious adverse events; VV, varicella vaccine.*Drowsiness and loss of appetite were recorded as solicited general AE from Day 0 to Day 3 in sub-cohort 1 only.
Figure 4. Study design.
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