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Table 2 Composition of the antigen-specific per protocol sets (PPSs)

From: Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro®) and a varicella vaccine (VARIVAX®) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial

 

IM Group

SC Group

 

Measles

Mumps

Rubella

Varicella

Measles

Mumps

Rubella

Varicella

Randomised

374

374

374

374

378

378

378

378

Vaccinated

374

374

374

374

378

378

378

378

Analysed in PPS

349

349

321

336

363

363

318

345

Not included in PPS1

25

25

53

38

15

15

60

33

- Seropositive at baseline

3

7

32

18

2

4

49

19

- Protocol deviations2

23

19

23

20

13

11

13

143

  1. (IM group, both vaccines administered by the intramuscular route; SC group, both vaccines administered by the subcutaneous route).
  2. 1 An infant could have more than one reason for not being included in the PPS, and some deviations do not apply to all valences; for example, data for one valence could be missing because there was not enough serum to perform the assay.
  3. 2 Protocol deviations included: previous vaccination for measles, mumps rubella or varicella; received non-study vaccine close to inclusion; route of vaccination different from that allocated by randomisation; initial serostatus unknown (first blood sample not taken or missing data), post-vaccination data missing (blood sample not taken or missing data); blood sample not taken at the right time; received only vaccine diluent.
  4. 3 Includes one subject exposed to varicella during follow-up.